2.3. Interventions
ulcer
ULCER
In this study, the patients were randomly assigned into 1 of the 3 groups for 12 weeks of intervention (a sample of 20 patients in each group). They were randomly allocated to each group with an allocation ratio of 1:1:1 by blindly selecting numbers from sealed envelopes, created by a random block randomization technique. All subjects in the three groups received the same conservative treatment for the ulcer in the form of wound cleaning, dressing, debridement if needed by the physician, and compression therapy. The wound dressing was changed 2–3 times a week, following the local protocol. The ulcer was cleaned with regular saline solution, and a nonadherent dressing, such as Vaseline gauze, was used to maintain a moist environment. All participants in the study received the same medical treatment protocol, which included the administration of phlebotropic drugs in the form of flavonoid medications, as well as topical application of antibiotic or antimicrobial agents (octenidine dihydrochloride antiseptic) [PEMF + PRE group: Patients received a local application of pulsed electromagnetic field therapy (PEMF) and a plantar flexion resistance exercise (PRE) therapy by the Step It rocker pedal (Step It System AB, Saltsjöbaden, Sweden) for up to 12 weeks. The entire exercise session duration was 20 min and involved a 10-min interval period for pedaling with the index leg for 1 min, interspersed by passive recovery for 1 min. This routine was performed twice daily (e.g., morning and evening). There would be at least 300 pedals using the minimum recommended 2 s down and 2 s up space [