Objectives To evaluate the feasibility of an interventional study involving a seated plantar resistance exercise programme, using a StepIt pedal, aimed at promotion of venous leg ulcer healing. Methods Thirty-two venous leg ulcer patients, recruited from community, GP and hospital settings, were randomised to either a standard care or adjuvant StepIt exercise programme arm for up to 12 weeks. The exercise involved a twice daily routine of 10 times 1 min of exercise, i.e. 2 s push and 2 s lift repetitions (equating to 300 daily ‘steps’). Results Complete healing of the venous leg ulcers was observed in 10 out of 15 (67%; StepIt cohort) and 7 out of 17 (41%; control cohort), respectively (p-value 0.18, Fisher’s exact test). Baseline differences between the two cohorts were longer wound chronicity, less venous leg ulcer-related pain and better venous leg ulcer-related quality of life in the StepIt cohort. One adverse event, involving increased wound exudate and slough production, was observed in a participant using StepIt, and no study withdrawals were recorded in either arm. StepIt users whose wound had completely healed by week 12 were more likely to be compliant with the exercise programme (self-reported) and more positive about the trial experience; however, all would recommend the device to others. Conclusions Seated plantar resistance exercise shows promise and may accelerate venous leg ulcer wound healing. The StepIt pedal is well-received by patients, and its efficacy may depend on the degree of patient compliance with the exercise programme. Further larger scale studies are indicated to allow more concrete inferences to be made on the clinical and potential health economics impact that this device may have.

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Compression bandaging is the mainstay therapy for chronic venous insufficiency and venous leg ulcers, but patient compliance can be challenging due to associated discomfort. The study discussed here aimed to compare AndoFlex TLC Calamine and Coban2 compression bandaging in relation to patient comfort and pruritus symptomology, with severity of pruritus as the primary outcome. This was a multi-centre, prospective, non-blinded, randomised controlled crossover trial involving 39 randomised patients with chronic venous insufficiency patients. In two periods, the patients wore AndoFlex TLC Calamine or Coban2 for 3 weeks each. No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test). However, after trying both bandages, 21 of the 35 patients (60%) definitely preferred AndoFlex TLC Calamine, whereas 4 patients (11%) definitely preferred Coban2. Thus, AndoFlex TLC Calamine compression bandage therapy was preferred by most patients, although this observation could not be confirmed using validated patient-reported outcome measures for pruritus. Further research is indicated to establish if patient preference translates into favourable clinical outcomes. ISRCTN number: ISRCTN95282887

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