Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers. Evaluation of SurePress Comfort: a new compression system for the management of venous leg ulcers. Management of stasis leg ulcers with Unna's boots versus elastic support stockings. A randomised controlled study of four-layer compression versus Unna's Boot for venous ulcers. A prospective, randomized trial of Unna's boots versus hydroactive dressing in the treatment of venous stasis ulcers. Unna's boot vs polyurethane foam dressings for the treatment of venous ulceration. A randomized prospective study. Randomized clinical trial and economic analysis of four-layer compression bandaging for venous ulcers. Randomized clinical trial of three-layer paste and four-layer bandages for venous leg ulcers. Combination of hydrocolloid dressing and medical compression stockings versus Unna's boot for the treatment of venous leg ulcers. Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration. Setopress vs Elastocrepe in chronic venous ulceration. Comparison of the effectiveness of compression stockings and layer compression systems in venous ulceration treatment. Comparison of the healing rates and complications of three four-layer bandage regimens. A prospective, randomized trial of Unna's boot versus Duoderm CGF hydroactive dressing plus compression in the management of venous leg ulcers. [Healing of venous leg ulcers. A randomized prospective study of a long-stretch versus short-stretch compression bandage]. Efficacy and tolerability of an ulcer compression stocking for therapy of chronic venous ulcer compared with a below-knee compression bandage: results from a prospective, randomized, multicentre trial. The influence of different sub-bandage pressure values on venous leg ulcers healing when treated with compression therapy. Cost effectiveness of community leg ulcer clinics: randomised controlled trial. Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers. Comparison of Rosidal K and SurePress in the treatment of venous leg ulcers. Trial of two bandaging systems for chronic venous leg ulcers. Short-stretch versus multilayer compression for venous leg ulcers: a comparison of healing rates. Randomized trial of four-layer and two-layer bandage systems in the management of chronic venous ulceration. Comparison of two occlusive bandages in the treatment of venous leg ulcers. A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers. Comparison of low-strength compression stockings with bandages for the treatment of recalcitrant venous ulcers. A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers. Comparison of elastic versus nonelastic compression in bilateral venous ulcers: a randomized trial. A randomized trial of the Tubulcus multilayer bandaging system in the treatment of extensive venous ulcers. [The impact of the sonotherapy and compression therapy on enhancement of healing venous leg ulcers after surgical treatment]. A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers.
Many venous ulcers are healed by the application of external compression. It has been suggested that bandages capable of producing greater compression enhance healing. The aim of this study was to compare the time to total healing of venous ulcers in two groups of patients treated with different compression regimens in a randomized prospective trial.
                A total of 112 patients was studied and all were treated with a zinc-impregnated paste bandage applied directly to the ulcer. Fifty-seven patients had the paste covered by Tensopress and 55 by Elastocrepe bandages. Both groups had a tubular bandage applied over the top to retain the bandage in place. All ulcers were stratified and randomized within one of three size groups. The 'venous' aetiology of the ulcer was confirmed on completion by calf pump function tests.
                By 26 weeks, 58 per cent of the patients treated with Tensopress and 62 per cent of those treated with Elastocrepe bandages were healed. The median healing times were 9 and 9.5 weeks respectively. Similar numbers of patients were excluded or withdrawn from both groups. Large ulcers healed significantly more slowly than small ulcers.
                There was no significant improvement in venous ulcer healing using higher compression elastic bandages. The primary aim was to compare the healing of venous leg ulcers after management with either a new compression stocking (SurePress Comfort, ConvaTec) or a standard short-stretch bandage system (Comprilan, BSN Medical GmbH & Co). Secondary parameters included healing rate, ease of application and removal, comfort during wear, local pain levels and concordance.
                This was a prospective multicentre open-label comparative randomised controlled parallel-group pilot trial of 12 weeks' duration.
                The proportion of ulcers that healed in 12 weeks (44.4% versus 17.2%, p=0.027) and the average time to healing (72 +/- 5 days versus 101 +/- 7 days, p=0.0265) were significantly better with SurePress Comfort than the comparator. All the secondary parameters (except concordance) also showed statistically significant differences for the stocking over the comparator.
                SurePress Comfort stocking system is more effective than a standard short-stretch compression bandage in healing venous leg ulcers and in reducing associated pain. It is well accepted by patients due to its ease of use and comfort, and its safety profile is comparable to that of a standard compression system. It may therefore provide an effective solution for the delivery of graduated compression and has the potential to improve concordance, compared with short- stretch bandages.
                This study was sponsored by ConvaTec. Twenty-one patients with stasis leg ulcers were randomly assigned to two groups. The first group was treated with Unna's boots, while the second was treated with elastic support stockings with graded compression from 24 mm/Hg pressure at the ankle to 16 mm/Hg pressure at the calf. The ulcers on seven of ten legs (70%) treated with Unna's boots and on 10 of 14 legs (71%) treated with elastic support stocking healed. Although the two groups were small, there was no statistically significant difference between their success rate in healing stasis leg ulcers (p = 0.9394). Both treatment groups showed significant changes in lower limb volume, calf circumference, and ankle circumference, although there was no statistically significant difference between the two groups. If healing times are calculated, however, the average healing time in the Unna boot-treated group was 7.3 weeks, while patients treated with support stockings took an average of 18.4 weeks. If one patient whose ulcerations almost encircled her calves and took 78 weeks to heal is excluded, patients treated with support stockings had an average healing time of 11.8 weeks. This study set out to compare healing rates, handling properties and patient comfort of a four-layer bandage system (Profore) and Unna's Boot in the treatment of venous leg ulcers.
                This was a prospective randomised parallel-group trial. Patients with venous leg ulcers from four centres in Italy were randomised to receive treatment with either Unna's Boot or Profore. Time to healing was recorded for a maximum of 24 weeks. Pain was assessed using a visual analogue scale. Staff assessed ease of application, while patients rated comfort.
                Data were available for 68 patients with 68 wounds. At 24 weeks complete healing was seen in 74% of the Profore group compared with 66% of the Unna's Boot group. The median time spent in the study was 50 days (range: 7-175 days), corresponding to 51 days (range: 7-175 days) for Profore patients and 49 days (range: 7-168 days) for Unna's Boot patients. There was no difference (p = 0.13) between the groups in time to closure. Overall, more Profore than Unna's Boot applications were rated as excellent. There was a significant difference, in favour of Profore, in ease of application at the final application (p = 0.013). At the initial application, there was a significant difference in bandage appearance (p = 0.04), again favouring Profore, but this was not sustained at the final application (p = 0.18).
                Profore is as effective as Unna's Boot in the treatment of venous leg ulcers. In many centers the standard treatment for venous stasis ulcers consists of UB dressings. A new dressing, DuoDERM hydroactive dressing (HD), has recently been used extensively for the treatment of venous stasis ulcers. Because of this trend, a prospective, randomized trial of these two dressings was undertaken. Sixty-nine ulcers (39 HD and 30 UB) were randomized. End points were complete healing and development of complications necessitating cessation of treatment. Time to healing, cost of treatment, and patient convenience were also evaluated. Twenty-one of 30 ulcers (70%) healed with UB therapy compared with 15 of 39 ulcers (38%) treated with HD (p less than 0.01, CST). Life-table healing rates at 15 weeks were 64% for UB compared with 35% for HD (p = 0.01, log rank test). Ten of 39 patients (26%) receiving HD had complications compared with no complications in the UB group (p = 0.004, FET). For those patients whose ulcers healed, there was no significant difference (p = 0.51, STT) in the mean time required for healing or the average weekly cost of dressing materials between the HD group (7.0 weeks at +11.50 per week) and the UB group (8.4 weeks at +12.60 per week). Those patients treated with HD reported a significantly greater level of convenience than those patients with UB (p = 0.004, STT). Although treatment with HD led to better patient acceptance, those patients receiving UB therapy had a significantly greater rate of healing and a significantly lesser incidence of complications than those patients treated with HD. Recent reports have suggested that polyurethane foam dressings provide a more rapid and comfortable healing of venous stasis cutaneous ulcerations than standard semirigid impregnated gauze dressings. This multi-institutional study consists of a randomized, prospective comparison of 36 consecutive patients who were treated with either polyurethane foam dressings (group 1, n = 17) or Unna's boot (group 2, n = 19) for venous ulceration of the lower extremities. Ulcer size ranged from 6.0 to 270 cm2 (mean, 32.2 cm2) for group 1 and 0.2 to 600 cm2 (mean, 76.0 cm2) for group 2. Nine (52.9%) of 17 group 1 patients withdrew from the study due to wound odor, while there was 100% compliance in group 2. Overall wound healing was superior in group 2 (18 [94.7%] of 19) as compared with group 1 (7 [41.2%] of 17) (chi 2 = 8.2). The rate of healing was also better in group 2 (0.5 cm2/d) than in group 1 (0.07 cm2/d). Contrary to published European trials, impregnated gauze dressings exhibited superior treatment results when compared with polyurethane foam dressings in the current study. The aim of this study was to compare the cost-effectiveness of four-layer compression bandaging for venous leg ulcers with that of other available treatments.
                In this pragmatic trial, 200 patients with a venous leg ulcer were randomized either to four-layer bandaging (intervention group; n = 100) or to continue their usual system of care (control group; n = 100). The follow-up for each patient was 12 weeks. Analysis was by intention to treat; the main outcome measures were time to healing and cost to the health board per leg healed.
                Baseline characteristics were well matched in the two groups. The Kaplan-Meier estimate of the healing rate at 3 months was 54 per cent with four-layer bandaging and 34 per cent in the control group. Throughout the 3 months, four-layer bandaging healed leg ulcers significantly earlier (P = 0.006). There was a significant reduction in the median cost per leg healed with four-layer bandaging (euro 210 versus euro 234; P = 0.040).
                Four-layer bandaging is currently the most effective method of treating venous leg ulcers in a community setting.
                Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Both four-layer and three-layer paste bandages are widely used in the treatment of venous leg ulcers. The aim of this study was to compare the efficacy of these two bandaging regimens.
                The study was a prospective, randomized, open comparison of a consecutive cohort of 133 patients with venous ulcers. Participants were stratified by ulcer size into one of three groups and were randomized within each group to receive either three-layer paste or four-layer bandages. All patients were followed for 1 year. The time taken to complete ulcer healing was the primary endpoint. The time taken to apply the bandages, comfort, tolerability and cost were also assessed. Analysis was performed on the basis of intention to treat.
                Ulcers healed completely in 51 (80 per cent) of 64 patients treated with three-layer paste bandages compared with 45 (65 per cent) of 69 patients treated with the four-layer regimen (P = 0.031). This difference developed only after 20 weeks of treatment. The median times to complete healing were 12 weeks for three-layer and 16 weeks for four-layer treatment (P = 0.040). Results of venous function tests, including half-refilling times, were similar in the two groups.
                Three-layer paste bandages were significantly more effective at healing venous ulcers than the four-layer regimen in this study.
                Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. Various therapeutic approaches have been developed to manage venous ulcers. In this study the effectiveness of a hydrocolloid dressing (Comfeel Ulcer Dressing) in comparison to the Unna boot, the prototype of rigid bandages, was evaluated.
                Design: Prospective, comparative study.
                University hospital.
                Sixty patients diagnosed with post-thrombotic chronic venous insufficiency with venous ulcers were randomly assigned to two groups of 30 patients. Interventions: In group A, the Unna boot, and in group B, hydrocolloid dressing in addition to the elastic compression were used. Measures: The two groups were compared in terms of 1) complete healing, 2) weekly wound surface reduction, 3) time to complete healing, 4) performance characteristics (ease-of-use score), 5) pain during application and at home, 6) application time.
                The duration of the ulcers was 16.6 +/- 5.8 weeks in group A and 16.9 +/- 6.2 in group B (p >0.05). Previous ulcer recurrence was 74% (20/27 patients) in group A and 73% (19/26 patients) in group B (p >0.05). The initial ulcer size was 6.38 +/- 1.2 cm2 in group A and 6.19 +/- 0.8 cm2 in group B (p >0.05). The complete healing rates were 74.07% (20/27) in group A and 80. 76% (21/26) in group B (p >0.05). The weekly wound surface reductions were 1.28 +/- 0.72 cm2/week and 1.16 +/- 0.38 cm2/week in groups A and B, respectively (p >0.05). The ulcer healing time was 6.85 +/- 3.60 weeks in group A, whereas it was 6.65 +/- 3.31 weeks in group B (p >0.05). Ease-of-use score was 9.04 +/- 2.38 in group A and 17.27 +/- 3.27 in group B and the difference was significant (p <0.0001). A higher degree of pain was reported by the patients who were treated with the Unna boot, both during application (group A 3.69 +/- 1.35, group B 1.88 +/- 1.48, p <0.0001) and at home (group A, 3.27 +/- 1.08, group B, 1.88 +/- 1.11, p <0.0001). The average time spent on Unna boot changes was 150.59 +/- 34.73 min, compared to 134.54 +/- 43.39 min in group B (p >0.05).
                These results demonstrate the superiority of hydrocolloid dressing plus elastic compression treatment in terms of patient convenience. A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index < 0.8) and causes of ulceration other than venous disease were excluded. For patients with bilateral ulceration, the limb with the larger area of ulceration was studied. Patients were randomized to receive either type of compression bandage and simultaneously randomized to one of two foam dressings that were changed weekly unless more frequent changes were clinically required. In all, 156 patients met entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33-123.10) cm(2). Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration, and one patient had died. Of the 74 patients randomized to the four-layer bandage, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on the cohesive short-stretch system. Intention-to-treat analysis produced a hazard ratio for healing of 1.08 (95 percent CI 0.63-1.85, p= 0.79). Withdrawal rates were similar between groups (15, 20% four-layer bandage; 17, 21% cohesive short-stretch system). Ulcer closure rates for patients treated with the cohesive short-stretch system were similar to those for patients managed by the four-layer bandage system in this trial. Venous ulceration is a major problem, particularly in the elderly population. It causes stress to the patient and treatment can be time-consuming. Compression therapy is considered to be the most appropriate non-invasive treatment of venous ulcers. It is generally accepted that composite bandage systems are most efficacious using a long-stretch or short-stretch bandage system. The study reported has compared a long-stretch bandage (Setopress) with a short-stretch bandage (Elastocrepe) over a 16-week period in the treatment of patients with venous ulceration. The trial was a prospective, randomized, observer-blind, parallel group study. Thirty-two patients (male and female) with a total of 39 ulcers completed the trial. After 15 weeks, 11 of 19 ulcers treated with the long-stretch bandage and 7 of 20 ulcers treated with the short-stretch bandage had healed. The differences were not statistically significant. After 15 weeks, the ulcer healing rate for the long-stretch bandage was 58% compared with 35% for the short-stretch bandage. The combined proportion of ulcers healed or improved was statistically significantly greater in the long-stretch bandage group. The aim of the research was to compare the dynamics of venous ulcer healing when treated with the use of compression stockings as well as original two- and four-layer bandage systems.
                A group of 46 patients suffering from venous ulcers was studied. This group consisted of 36 (78.3%) women and 10 (21.70%) men aged between 41 and 88 years (the average age was 66.6 years and the median was 67). Patients were randomized into three groups, for treatment with the ProGuide two-layer system, Profore four-layer compression, and with the use of compression stockings class II. In the case of multi-layer compression, compression ensuring 40 mmHg blood pressure at ankle level was used.
                In all patients, independently of the type of compression therapy, a few significant statistical changes of ulceration area in time were observed (Student's t test for matched pairs, p < 0.05). The largest loss of ulceration area in each of the successive measurements was observed in patients treated with the four-layer system - on average 0.63 cm2/per week. The smallest loss of ulceration area was observed in patients using compression stockings - on average 0.44 cm(2)/per week. However, the observed differences were not statistically significant (Kruskal-Wallis test H = 4.45, p > 0.05).
                A systematic compression therapy, applied with preliminary blood pressure of 40 mmHg, is an effective method of conservative treatment of venous ulcers. Compression stockings and prepared systems of multi-layer compression were characterized by similar clinical effectiveness. This randomised controlled study compares the healing rates, complications and patient and staff acceptability of three four-layer bandage regimens for leg ulcers. A total of 149 patients were recruited into the study, of whom 50 received the original Charing Cross system (CX4L), 50 a modified Charing Cross system (Parema) and 49 a commercially available kit, Robinson Ultra Four (Robinson). No significant difference was found in the healing rates of the three systems. Overall 12 weeks' healing was 65%, while the 20-week healing rates for the individual systems were 87% (CX4L), 84% (Parema) and 83% (Robinson). Analysis of known risk factors for delayed healing showed that no bandaging system had an advantage over the others. Staff familiarity resulted in an initial preference for the CX4L but there was no bandage preference by the end of the study. The data suggest that none of the systems has an advantage over the others and that cost savings can be made by pursuing a competitive pricing policy. Leg ulcers caused by chronic venous insufficiency plague an estimated 500,000 Americans, but there have been few improvements in conservative treatment in this century, and Unna's boot continues to be a mainstay of therapy. A recent report suggests that Duoderm CGF dressing provides greater patient comfort and enhanced compliance, but Duoderm alone (without compression) resulted in slower healing compared with Unna's boot. We enrolled 30 patients (30 ulcers) in a clinical trial to compare Duoderm CGF plus compression (Coban wrap) to Unna's boot. No significant difference was observed between the two groups with respect to age, sex, initial ulcer area, ulcer duration, or extent of venous insufficiency by duplex scan. Eight of 16 ulcers (50%) in the Duoderm group healed completely versus 6 of 14 ulcers (43%) in the Unna's boot group (p = 0.18). Healing rates (square centimeters per week) correlated significantly with initial ulcer area and initial ulcer perimeter for both groups but best correlated with initial ulcer perimeter (r = 0.88 with Duoderm, p less than 0.0001; r = 0.80 with Unna's boot, p less than 0.002). After adjusting for differences in initial ulcer perimeter, healing rates were significantly faster for patients on Duoderm than patients on Unna's boot during the first 4 weeks of therapy (0.384 +/- 0.059 cm2/wk/cm perimeter for Duoderm versus 0.135 +/- 0.043 cm2/wk/cm perimeter for Unna's boot; p = 0.002). At 12 weeks patients on Duoderm again appeared to heal faster than those on Unna's boot, although the result did not reach statistical significance (0.049 +/- 0.007 cm2/wk/cm perimeter for Duoderm versus 0.020 +/- 0.017 for Unna's boot, p = 0.11).(ABSTRACT TRUNCATED AT 250 WORDS) The aim of the study was to compare the efficacy of two types of compression bandage with different degrees of elasticity on healing of venous leg ulcers. Forty-three patients with venous leg ulcers were included and blindly randomized to treatment with one of the two types of bandage aiming at a sub-bandage pressure in the ankle area of 40 mmHg. Forty legs were evaluated. Healed ulcers after 12 months were observed in 71% of the long-stretch group and in 30% of the short-stretch group (p = 0.06). Using life-table analysis the predicted healing rate in the long-stretch group after 12 months was 81% and for the short-stretch group 31% (p = 0.03). The mean of relative ulcer areas at 12 months was 0.25 for the long-stretch group and 0.95 for the short-stretch group (p = 0.01). The present study appears to indicate a positive influence of the elasticity of a compression bandage applied with a sub-bandage pressure around 40 mmHg in the ankle area on venous ulcer healing. To investigate the possibility of improving healing rates in ulcus cruris venosum by using an ulcer compression stocking (U-Stocking) (Venotrain ulcertec) as compared to compression bandages. RESEARCH DESIGN AND SETTING: Prospective, multicentre, open-labelled, randomized, active-controlled study with blinded assessment of the primary endpoint. Sixteen phlebology outpatient clinics in Germany or the Netherlands or German medical practices specialized in phlebology.
                134 patients with venous leg ulcers entered the study. Among others, patients with infected ulcer or obesity were excluded. 121 patients were eligible for primary efficacy analyses. U-Stocking or bandages applied for at least eight hours per day and for up to 12 weeks. The primary endpoint was the healing rate after 12 weeks as assessed by planimetric measures. The secondary outcome variables were time to healing, changes in ulcer size (planimetry), experience of use and patient compliance.
                Therapy with the U-Stocking produced a significantly higher rate of complete healing of 47.5% (29/61) versus 31.7% (19/60) with bandages, 1-sided p = 0.0129 [CI: 95% for differences: 4.3% to 28.5%]. Mean time to healing was 46 days in both groups. Time required for application of the U-Stocking was a mean of 5.4 min (SD 5.4) versus 8.5 min (SD 6.5) for bandages, p = 0.0001. Around three patients in each treatment group were affected by serious adverse events. All treatment-related adverse events are known for compression therapy.
                The U-Stocking was superior to bandages in compression therapy for venous ulcer. This is of significance to new treatment standards as well as to future studies of longer term therapy (> 12 weeks) for unhealed ulcers or prevention of recurrence. Venous leg ulcers (VLU) have a huge social and economic impact. An estimated 1.5% of European adults will suffer a venous ulcer at some point in their lives. Despite the widespread use of bandaging with high pressure in the treatment of this condition, recurrence rates range between 25% to 70%. Numerous studies have suggested that the compression system should provide sub-bandage pressure values in the range from 35 mm Hg to 45 mm Hg in order to achieve the best possible healing results.
                An open, randomized, prospective, single-center study was performed in order to determine the healing rates of VLU when treated with different compression systems and different sub-bandage pressure values. One hundred thirty-one patients (72 women, 59 men; mean age, 59-years-old) with VLU (ulcer surface >3 cm(2); duration >3 months) were randomized into three groups: group A - 42 patients who were treated using an open-toed, elastic, class III compression device knitted in tubular form (Tubulcus, Laboratoires Innothera, Arcueil, France); group B - 46 patients treated with the multi-component bandaging system comprised of Tubulcus and one elastic bandage (15 cm wide and 5 cm long with 200% stretch, Niva, Novi Sad, Serbia); and group C - forty-three patients treated with the multi-component bandaging system comprised of Tubulcus and two elastic bandages. Pressure measurements were taken with the Kikuhime device (TT MediTrade, Soro, Denmark) at the B1 measuring point in the supine, sitting, and standing positions under the three different compression systems.
                The median resting values in the supine and standing positions in examined study groups were as follows: group A - 36.2 mm Hg and 43.9 mm Hg; group B - 53.9 mm Hg and 68.2 mm Hg; group C - 74.0 mm Hg and 87.4 mm Hg. The healing rate during the 26-week treatment period was 25% (13/42) in group A, 67.4% (31/46) in group B, and 74.4% (32/43) in group C. The success of compression treatment in group A was strongly associated with the small ulcer surface (<5 cm(2)) and smaller calf circumference (CC; <38 cm). On the other hand, compliance in group A was good. In groups B and C, compliance was poor in patients with small CC, but the healing rate was high, especially in patients with large ulcers and a large CC (>43 cm).
                The results obtained in this study indicate that better healing results are achieved with two or multi-component compression systems than with single-component compression systems and that a compression system should be individually determined for each patient according to individual characteristics of the leg and CC. Target sub-bandage pressure value (B1 measuring point in the sitting position) of the compression system needed for the ulcer healing could be determined according to a simple formula, CC + CC/2. To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses.
                Randomised controlled trial with 1 year of follow up.
                Eight community based research clinics in four trusts in Trent.
                233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group.
                Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group).
                Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored.
                The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2. 03). No significant differences were found between the groups in health status. Mean total NHS costs were 878.06 pounds per year for the clinic group and 859.34 pounds for the control (P=0.89).
                Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used. Aim of the study was to compare the healing rates of venous ulcers obtained with four-layer bandages (4LB) versus short stretch bandages (SSB).
                Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore Austrian Dutch Study).
                112 patients (53 treated with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the study. Bandaging and ulcer assessment was performed at weekly intervals. Randomisation was carried out for each centre and was stratified according to the size (more or less than 10 cm2) of the ulcerated area. Local therapy consisted of plain absorbing, non-adherent dressings. Time to complete healing was recorded up to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics.
                In total 33/53 (62%) of ulcer-patients were healed in the 4LB group, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI -28% to 7%). 77% of the ulcers with an initial area less than 5 cm2 healed as compared with 33% of the larger ulcers. The different healing rates in the centres could be explained by the different sizes of the treated ulcers. Based on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% CI 47-85 days) and 63 days for the SSB (95% CI 43-70 days).
                The ulcer healing rate and the median healing time did not differ among the two types of bandages. The main discriminant criterion for healing was the initial ulcer size. In centres who are experienced users of short-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB. Fifty-two patients (26 in each group) were recruited into this randomized, comparative, controlled trial of Rosidal K short-stretch compression bandage and SurePress long-stretch compression bandage in the treatment of venous leg ulcers. Patients were monitored for a maximum of 12 weeks. Each patient was seen weekly by a research nurse, who recorded the study variables. The mean percentage reduction in the wound bed surface area during the study period was 52% in the SurePress group and 73% in the Rosidal K group. Eight patients in each group saw their ulcers heal within the study period. The average limb volume reduction, based on the first 4 weeks of data collection, was 2.3 cm for those in the Rosidal K group and 3.9 cm in the SurePress group. Ulcer size increased in six patients allocated to SurePress bandages and in four patients allocated to Rosidal K bandages. A four-layer bandaging system developed at Charing Cross Hospital has been found to be effective in healing chronic venous ulcers but is not available on the Drug Tariff. An alternative system was devised from bandages available on the Drug Tariff and a community-based randomised controlled trial was undertaken to compare the two systems. Twenty-nine patients with a total of 35 ulcerated legs were recruited. Equal numbers of ulcerated legs healed using the two compression systems. Nineteen ulcerated legs did not heal, of which six were withdrawn from the trial-two in the trial system and four in the Charing Cross system. Of the 13 remaining ulcerated legs, for which treatment was completed, the mean reduction in ulcer area was 34% with the trial system and 39% with the Charing Cross system. The change in ulcer area was not statistically significant. However, a much larger trial is required in order to demonstrate definitively that the two bandaging systems are equivalent. To compare the performance of two compression systems, (multilayer elastic [Profore], Smith and Nephew) and (short stretch [Comprilan], Beiersdorf), in the treatment of venous leg ulcers in a randomised controlled trial.
                Eighty-nine patients with venous leg ulcers were randomised to receive treatment with Profore (44 patients) or short-stretch (45 patients) compression bandages. Allevyn (Smith and Nephew) was used as the wound contact layer under both systems.
                Patients treated with Profore healed significantly faster than those treated with short stretch (p = 0.03) and were 2.9 times more likely to heal at any given time during the study period. Younger wounds healed significantly faster than older wounds (p = 0.01).
                Patients treated with Profore healed faster than those treated with short-stretch bandages. In addition, treatment costs are lower with Profore. In this trial the average cost per patient was [symbol: see text] 1345 (short stretch) and [symbol: see text] 587 (Profore). To compare a four-layer bandage system with a two-layer system in the management of chronic venous leg ulceration, a prospective randomized open parallel groups trial was undertaken. In total, 112 patients newly presenting to leg ulcer services with chronic leg ulceration, screened to exclude the presence of arterial disease (ankle brachial pressure index <0.8) and causes of ulceration other than venous disease, were entered into the trial. Patients were randomized to receive either four-layer (Profore) or two-layer (Surepress) high-compression elastic bandage systems. In all, 109 out of 112 patients had at least one follow-up. After 24 weeks, 50 out of 57 (88%) patients randomized to the four-layer bandage system with follow-up had ulcer closure (full epithelialization) compared with 40 out of 52 (77%) on the two-layer bandage, hazard ratio = 1.18 (95% confidence interval 0.69-2.02), p = 0.55. After 12 weeks, 40 out of 57 (70%) patients randomized to the four-layer bandage system with follow-up had ulcer closure compared with 30 out of 52 (58%) on the two-layer bandage, odds ratio = 4.23 (95% confidence interval 1.29-13.86), p = 0.02. Withdrawal rates were significantly greater on the two-layer bandage (30 out of 54; 56%) compared with the four-layer bandage system (8 out of 58; 14%), p < 0.001, and the number of patients with at least one device-related adverse incident was significantly greater on the two-layer bandaging system (15 out of 54; 28%) compared with four-layer bandaging (5 out of 54; 9%), p = 0.01. The higher mean cost of treatment in the two-layer bandaging system arm over 24 weeks ($1374 [ pound 916] vs. $1314 [ pound 876]) was explained by the increased mean number of bandage changes (1.5 vs. 1.1 per week) with the two-layer system. In conclusion, the four-layer bandage offers advantages over the two-layer bandage in terms of reduced withdrawal from treatment, fewer adverse incidents, and lower treatment cost. A randomized controlled study was performed in 34 patients with venous leg ulcers. No difference was found in the healing rate between a new hydrocolloid dressing plus compression, and a double layer bandage, consisting of an inner paste bandage (i.e. a stocking impregnated with zinc oxide paste) and an outer elastic bandage. The parameters chosen for objective evaluation were stereophotogrammetric measurement of ulcer area and volume, and bacterial counts. This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB. To compare the proportion and rate of healing, pain, and quality of life of low-strength medical compression stockings (MCS) with traditional bandages applied for the treatment of recalcitrant venous leg ulcers.
                A single-center, randomized, open-label study was performed with consecutive patients. Sigvaris prototype MCS providing 15 mm Hg-25 mm Hg at the ankle were compared with multi-layer short-stretch bandages. In both groups, pads were placed above incompetent perforating veins in the ulcer area. The initial static pressure between the dressing-covered ulcer and the pad was 29 mm Hg and 49 mm Hg with MCS and bandages, respectively. Dynamic pressure measurements showed no difference. Compression was maintained day and night and changed every week. The primary endpoint was healing within 90 days. Secondary endpoints were healing within 180 days, time to healing, pain (weekly Likert scales), and monthly quality of life (ChronIc Venous Insufficiency Quality of Life [CIVIQ] questionnaire).
                Of 74 patients screened, 60 fulfilled the selection criteria and 55 completed the study; 28 in the MCS and 27 in the bandage group. Ulcers were recurrent (48%), long lasting (mean, 27 months), and large (mean, 13 cm2). All but one patient had deep venous reflux and/or incompetent perforating veins in addition to trunk varices. Characteristics of patients and ulcers were evenly distributed (exception: more edema in the MCS group; P = .019). Healing within 90 days was observed in 36% with MCS and in 48% with bandages (P = .350). Healing within 180 days was documented in 50% with MCS and in 67% with bandages (P = .210). Time to healing was identical. Pain scored 44 and 46 initially (on a scale in which 100 referred to maximum and 0 to no pain) and decreased within the first week to 20 and 28 in the MCS and bandage groups, respectively (P < .001 vs .010). Quality of life showed no difference between the treatment groups. In both groups, pain at 90 days had decreased by half, independent of completion of healing. Physical, social, and psychic impairment improved significantly in patients with healed ulcers only.
                Our study illustrates the difficulty of bringing large and long-standing venous ulcers to heal. The effect of compression with MCS was not different from that of compression with bandages. Both treatments alleviated pain promptly. Quality of life was improved only in patients whose ulcers had healed.
                Copyright 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved. We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration.
                A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat.
                There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0).
                Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings. There is controversy regarding the effectiveness of elastic vs nonelastic compression in the healing of venous leg ulcers. To gain insight into this controversy, we randomly compared a four-layer elastic bandage with a nonelastic garment (CircAid) in patients with venous leg ulcers.
                Twenty-four extremities of 12 patients with bilateral leg ulcers were randomized to have a four-layer elastic bandage in 1 extremity and a nonelastic compression garment CircAid in the contralateral limb. The CEAP classification in 22 extremities was C(6 S); ES; A(D6,14,15,P18); PR; 1 extremity in 2 patients was C(6 S); E(S); A(D 6,14,15,P18); PRO. There were seven men and five women. Age ranged from 45 to 82 years, with a mean of 61 years. All patients had postthrombotic leg ulcers diagnosed clinically by duplex ultrasonography (n = 8) or by phlebography (n = 4). Every 4 weeks, patients had the ulcer area measured in square centimeters by a computerized scanning method and had the limb girth measured in centimeters at the foot, ankle, and calf. The ankle-brachial index was determined in all cases. Color photographs of the ulcer areas were taken monthly to assess healing progress. All patients were compliant. Results were assessed at 12 weeks. A patient satisfaction sheet was filled out by the patient, who circled one of the following scores: 3, very satisfied; 2, moderately satisfied; and 1, not satisfied. Cox proportional hazards models or paired t tests were used for comparison.
                The 24 limbs were randomized and divided into 2 groups of 12 each. Group A received CircAid, and group B, a four-layer elastic bandage. Duplex scanning showed a pattern of reflux in 11 limbs of each group. One limb in each group had a pattern of obstruction documented by air plethysmography (n = 2). Phlebography demonstrated the anatomic site in both limbs. The initial ulcer area in group A was 48.98 +/- 14.13 cm2 and was 50.08 +/- 18.30 cm2 in group B (P = .9285). The ulcer healing rate was significantly faster in group A compared with group B (hazard ratio, 0.56; 95% confidence interval, 0.33-0.96; P = .0173). Ulcers with hemodynamic obstruction had a protracted course when compared with the contralateral limbs with reflux. There was no significant difference in girth reduction between groups A and B (hazard ratio, 2.36; 95% confidence interval, 0.30-18.52; P = .3580). The ankle-brachial index was normal (> or = 1.0) in all patients.
                In compliant patients, venous leg ulcers randomized to nonelastic compression had a significantly faster healing rate per week than ulcers treated by the conventional four-layer compression system. Venous ulcers are a major health problem because of their high prevalence and associated high cost of care. Compression therapy is the most widely used treatment for this condition. The vast majority of published articles on compression therapy present the results in the treatment of venous ulcers usually up to 15 to 20 cm(2). However, there are no published data in English medical literature on the efficacy of compression therapy in the treatment of extensive venous ulcers (ulcers >20 cm(2) of more than 6 months' duration) with regard to healing rate, time to healing, and recurrence rate at 12 months after healing.
                A total of 138 patients with extensive venous ulceration (ulceration surface, 20-210 cm(2); duration, 7 months to 28 years) were randomized into 2 groups: (1) a treatment group (72 patients who were treated by using a multilayer bandaging system with the Tubulcus (a heelless open-toed elastic compression device knitted in tubular form) and elastic bandages and (2) a control group (66 patients treated with a multilayer bandaging system with elastic bandages only). The patients were treated on an ambulatory basis; the primary end point of the study was complete ulcer healing at 500 days. The secondary end point was to assess the ulcer recurrence rate during continuation of below-knee compression of different degrees of compression. In the treatment group, patients were instructed to continue to wear the Tubulcus (35 mm Hg), and patients in the control group were instructed to wear compression stockings with compression of 20 to 25 mm Hg. The exclusion criteria from the study were heart insufficiency with an ejection fraction <35, an ankle-brachial pressure index less than 0.8, and pregnancy.
                The cumulative healing rate was 93% in the treatment group and was 51% in the control group (P < .001). The median healing time in the treatment group was 133 days (range, 28 to 464 days), and in the control group it was 211 days (range, 61 to 438 days). The recurrence rate at 12 months in the treatment group was 24% (16/67) and was 53% (18/34) in the control group (P < .05). After additional compression treatment with the same treatment protocol, all 16 recurrent ulcers in the treatment group healed. In the control group, the healing rate of recurrent ulcers was 89% (16/18).
                This study suggests that for extensive venous ulceration, multilayer compression therapy with the Tubulcus provides an extremely high healing rate. Compression of more than 30 mm Hg results in decreased ulcer recurrence. However, recurrence cannot be completely avoided. The aim of this paper was to describe the impact of the sonotherapy and compression therapy on enhancement of healing venous leg ulcers after surgical treatment.
                Three comparative groups of patients--A, B and C were made at random from patients with venous leg ulcers, which had been earlier operated by modified Babcock' method. The 24 patients were included (in use of software Monte Carlo) to the group A, 25 patients to the group B and 24 patients to the group C (control group). The patients in all comparative groups were treated pharmacologically. Ulcerations at patients in group A were additionally treated in use of ultrasound. And ulcerations at patients in group B were additionally treated in use of compression therapy. The evaluated factors were to estimate the sonotherapy and compression therapy causes any changes of the surface, longest and widest dimensions, and volume of tissue defect. For all comparative groups calculated the Gilman parameter. The weekly speed of changes of surface and volume were estimated too.
                After therapy there was statistically significant decrease of whole surface and pus-covered and granulation area, longest and widest dimensions, and volume of ulcers in all groups while there was no statistically significant difference--except pus-covered areas--between the groups observed. Comparison in terms of pus-covered area indicated a significant difference between all groups, in favor groups A and B than C.
                There are no special reasons for application of ultrasound and compression therapy in enhancement of healing process--however the following results must be verified on bigger population and longer patient observation. The sonotherapy and compression therapy promote only decontamination process compared with control group. This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.
Compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear to be more effective than those composed mainly of inelastic constituents. Two-component bandage systems appear to perform as well as the 4LB. Patients receiving the 4LB heal faster than those allocated the SSB. More patients heal on high-compression stocking systems than with the SSB. Further data are required before the difference between high-compression stockings and the 4LB can be established.