Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial Preventing diabetic foot disease: lessons from the Medicare therapeutic shoe demonstration. Randomized controlled trial for clinical effects of varying types of insoles combined with specialized shoes in patients with rheumatoid arthritis of the foot. Efficacy of custom foot orthotics in improving pain and functional status in children with juvenile idiopathic arthritis: a randomized trial. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. [Orthopedic made-to-measure shoes for diabetics. Long-term 5-year outcome]. Manufactured Shoes in the Prevention of Diabetic Foot Ulcers [Insoles for the rheumatic foot. A clinical and pedobarographic analysis].
Background Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence . Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts . While casting in plaster is usually effective in achieving primary closure of foot ulcers , recurrence rates are high . Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results . The surgery alleviates the pressure under the bony prominence , thus enabling prompt ulcer healing , negating the patient ’s dependence on expensive shoes and orthotics , with a lower chance of recurrence . The purpose of this protocol is to compare offloading surgery ( percutaneous flexor tenotomy , mini-invasive floating metatarsal osteotomy or Keller arthroplasty ) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover design ed RCT . Methods One hundred patients with diabetic neuropathy related foot ulcers ( tip of toe ulcers , ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint ) will be r and omized ( 2:3 ) to a surgical offloading procedure or best available non-surgical treatment . Group 1 ( surgery ) will have surgery within 1 week . Group 2 ( controls ) will be prescribed an offloading cast applied for up to 12 weeks ( based on clinical considerations ) . Following successful offloading treatment ( ulcer closure with complete epithelization ) patients will be prescribed orthopaedic shoes and custom made orthotics . If offloading by cast for at least 6 weeks fails , or the ulcer recurs , patients will be offered surgical offloading . Follow-up will take place till 2 years following r and omization . Outcome criteria will be time to healing of the primary ulcer ( complete epithelization ) , time to healing of surgical wound , recurrence of ulcer , time to recurrence and complications . Discussion The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present . To promote surgery , RCT level evidence of efficacy is necessary . Trial registration Israel MOH_2017–08 - 10_000719 . NIH : NCT03414216 OBJECTIVES Every year about 38,000 elderly people with diabetes have a  lower extremity amputation .  Therapeutic shoes are prescribed by clinicians specializing in foot care to prevent foot ulcerations and amputations among at-risk patients with diabetes . Medicare ran a 3-year demonstration of a therapeutic-shoe benefit for beneficiaries with diabetes . Medicare added the benefit nationwide in May 1993 . METHODS This paper describes the benefit and its implementation in the demonstration based on demonstration records , a patient survey , and discussion s with clinicians and shoe suppliers before and during the demonstration . RESULTS During the demonstration , far fewer beneficiaries applied for the therapeutic shoes than were eligible for them . The paper discusses reasons for the low beneficiary application rate and the associated low participation rate among physicians treating patients with diabetes . CONCLUSIONS The benefit is unlikely to be used any more in the national program than in the demonstration unless physicians are educated in the role therapeutic shoes can play in diabetic foot disease , they prescribe the shoes for their patients , and they increase their patients ' awareness of the shoes ' value OBJECTIVE To determine the effects of specialized shoes with insoles in patients with rheumatoid arthritis and the differences in terms of type of insole and anatomical location of foot pathology . DESIGN Single-blinded r and omized controlled trial . SETTING Out patients of physical medicine and rehabilitation clinic at university hospital . SUBJECTS Forty-two patients with rheumatoid foot lesions were r and omly assigned to two different orthotic intervention groups . The anatomical locations of the foot lesions were recorded ( hindfoot or forefoot ) . INTERVENTION Participants were provided with an extra deep forefoot-rockered shoe and either a custom-made semi-rigid insole or a ready-made simple soft insole . They wore the provided footwear for at least 3 hours a day over six months . MAIN OUTCOME MEASURES Primary outcome measures were foot pain visual analogue scale ( VAS ) scores and Foot Function Index ( FFI ) . Secondary outcome measures were erythrocyte sedimentation rate and C-reactive protein levels in blood , amounts of medications and active joint counts . These were checked at baseline and post intervention . RESULTS Eight patients dropped out at follow-up after six months of treatment . At six-month follow-ups , VAS scores and total Foot Function Index scores had decreased significantly in both groups versus baseline but intergroup comparison showed no significant differences in view of type of insoles and anatomical locations of foot pathology . CONCLUSIONS We were unable to identify differences between the types of insoles in terms of their clinical effects or between anatomical locations of foot lesions in the two groups , but both groups improved . Therapeutic shoes plus soft insoles might be effective enough in terms of foot pain and foot function for specific patients with rheumatoid foot problems regardless of the location of foot pathology OBJECTIVE . To compare the clinical efficacy of custom foot orthotics , prefabricated " off-the-shelf " shoe inserts , and supportive athletic shoes worn alone , on reducing pain and improving function for children with juvenile idiopathic arthritis ( JIA ) . METHODS Children with JIA and foot pain ( n = 40 ) were r and omized to one of 3 groups receiving : ( 1 ) custom-made semirigid foot orthotics with shock absorbing posts ( n = 15 ) , ( 2 ) off-the-shelf flat neoprene shoe inserts ( n = 12 ) , or ( 3 ) supportive athletic shoes with a medial longitudinal arch support and shock absorbing soles worn alone ( n = 13 ) . Foot pain and functional limitations were measured using the Pediatric Pain Question naire-visual analog scale ( VAS ) , Timed Walking , Foot Function Index ( FFI ) , and the Physical Functioning Subscale of the Pediatric Quality of Life Inventory ( PedsQL ) . Measures were administered by personnel blinded to group status at baseline ( before wearing the assigned intervention ) and at 3 months ' followup . RESULTS Children in the orthotics group showed significantly greater improvements in overall pain ( p = 0.009 ) , speed of ambulation ( p = 0.013 ) , activity limitations ( p = 0.002 ) , foot pain ( p = 0.019 ) , and level of disability ( p = 0.024 ) when compared with the other 2 groups . Both children and parents in the orthotics group reported clinical ly meaningful improvement in child health-related quality of life , although the group by time interaction did not show statistical significance . Except for a reduction in pain for supportive athletic shoes ( paired t test , p = 0.011 ) , neither the off-the-shelf shoe inserts nor the supportive athletic shoes worn alone showed significant effect on any of the evaluation measures . CONCLUSION In children with JIA , custom-made semirigid foot orthotics with shock-absorbing posts significantly improve pain , speed of ambulation , and self-rated activity and functional ability levels compared with prefabricated off-the-shelf shoe inserts or supportive athletic shoes worn alone CONTEXT Many people with diabetes experience lower-limb ulcers . Footwear has been implicated as a primary cause of foot ulcers , yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration . OBJECTIVE To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years . Data collected at regular intervals documented physical , foot , and diabetes characteristics ; footwear use ; foot lesions ; and ulcers . INTERVENTIONS Participants were r and omly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover ( n = 121 ) ; to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated , tapered polyurethane inserts with a brushed nylon cover ( n = 119 ) ; or to wear their usual footwear ( controls ; n = 160 ) . MAIN OUTCOME MEASURE Foot reulceration , compared among the 3 groups . RESULTS Two-year cumulative reulceration incidence across the 3 groups was low : 15 % in the cork-insert group , 14 % in the prefabricated-insert group , and 17 % in controls . In the intent-to-treat analysis , patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls ( risk ratio [ RR ] for the cork-insert group , 0.88 ; 95 % confidence interval [ CI ] , 0.51 - 1.52 and RR the for prefabricated-insert group , 0.85 ; 95 % CI , 0.48 - 1.48 ) . All ulcer episodes in patients assigned to therapeutic shoes and 88 % wearing non study shoes occurred in patients with foot insensitivity . CONCLUSIONS This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer . Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear . This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities For patients with diabetes mellitus and diabetic foot syndrome  customized orthopedic shoes represent the most effective treatment to avoid foot ulceration and amputation .  A total of 53 patients suffering from diabetes and treated with customized orthopedic shoes for more than 5 years were included in the study . Of the patients 91 % had peripheral artery occlusion disease , polyneuropathy and diabetic neuropathic osteoarthropathy ( DNOAP ) and in nearly 25 % amputation of one limb had already been carried out . The incidence of ulcers over a time period of 5 years was assessed from the patient records and question ing the patients . Questions on the duration of wearing orthopedic shoes , the durability of the shoes and result ing pain were also included . All patients except for one had problems walking on uneven surfaces . Of the patients 89 % cl aim ed to have used their shoes always or nearly always and 25 % of the shoes had to be replaced after 1 year . The incidence of ulcers was 38 % after 5 years . Treatment with customized orthopedic shoes is an effective method to prevent ulcers and amputation . To be successful it is necessary to control that the shoes are made correctly . Not all shoes last as long as 2 years OBJECTIVE To evaluate the efficacy of manufactured shoes specially design ed for diabetic patients ( Podiabetes by Buratto Italy ) to prevent relapses of foot ulcerations . RESEARCH DESIGN AND METHODS A prospect i ve multicenter r and omized follow-up study of patients with previous foot ulcerations was conducted . Patients were alternatively assigned to wear either their own shoes ( control group , C ; n = 36 ) or therapeutic shoes ( Podiabetes group , P ; n = 33 ) . The number of ulcer relapses was recorded during 1-year follow-up . RESULTS Both C and P groups had similar risk factors for foot ulceration ( i.e. , previous foot ulceration , mean vibratory perception threshold > 25 mV ) . After 1 year , the foot ulcer relapses were significantly lower in P than in C ( 27.7 vs. 58.3 % ; P = 0.009 ; odds ratio 0.26 [ 0.2–1.54 ] ) . In a multiple regression analysis , the use of therapeutic shoes was negatively associated with foot ulcer relapses ( coefficient of variation = −0.315 ; 95 % confidence interval = −0.54 to −0.08 ; P = 0.009 ) . CONCLUSIONS The use of specially design ed shoes is effective in preventing relapses in diabetic patients with previous ulceration BACKGROUND Insoles are regarded as an appropriate tool for the management of rheumatic foot disorders . However , a quality control for this purpose has not been established . In our study , the clinical effectiveness of insoles used in patients with rheumatic foot disorders was addressed . In addition , we sought to establish pedobarography as a means of quality control for orthotic management of the rheumatic foot . MATERIAL AND METHODS Our study included 20 rheumatoid arthritis patients with painful rheumatic foot deformities who were provided with insoles .  Clinical data were obtained by physical examination and a 100-mm pain scale . Pedobarography was performed using the novel pedar cable system with new and individually design ed insoles and after a 6-month follow-up . A shoe-only trial served as control . The parameters maximum force , peak pressure , force-time integral , and average pressure were analyzed in anatomical regions and an individually defined overloaded forefoot region . RESULTS Clinical improvement was significant after a 6-month follow-up in spite of a heterogeneous group of patients . However , our results could not confirm consistent changes in plantar pressure distribution . CONCLUSION As a conclusion , further efforts are necessary to establish a quality control for orthotic management of the rheumatic foot
The present review shows that current scientific literature concerning the usability of orthopaedic shoes focuses mainly on effectiveness at the expense of the other domains of usability , i.e. , efficiency , satisfaction and context of use
Objective : To determine the method ological quality of studies evaluating  orthopaedic shoes and orthopaedic shoe provisions .
To what extent do studies evaluating  orthopaedic shoes prescribed for patients with degenerative disorders of the foot , rheumatoid arthritis , diabetes mellitus and neurological foot disorders , focus on the aspects of the International Organization for St and ardization ( ISO ) definition of usability , i.e. , effectiveness , efficiency , satisfaction , and context of use ?