A multicentre randomised research trial assessing the effectiveness and acceptability of a calf muscle exercise device for supportive treatment of venous leg ulcers

INTERVENTION: Following written consent patients will be allocated at random to the control or intervention group, using a non‐restricted randomised sequence generated for the whole sample using a free ware randomisation programme, see https://www.randomizer.org/ . The randomisation will be stratified for VLU size, with one group being those with a PUSH score of 8 or lower and the other with a PUSH score of 9 or higher. Sequential envelopes with each next randomisation allocation will be used to achieve concealment. It is recognised that random selection does not guarantee representativeness but variables which may affect the outcome variable are more likely to be balanced out and reliability enhanced (Thomas 1990). As the study involves a self‐administered intervention of necessity it is not possible to achieve blinding for the participants. Due to the pilot nature of this study, the researcher will not be blinded either to the subjects intervention, although this can be considered as part of a larger trial since it would further reduce any risk of bias. However, the primary outcome measure, size of the VLU is a quantitative outcome measure which is less prone to bias than for example a patient reported outcome measure or a clinician reported outcome measure. Control group: Participants receive treatment as usual, which involves compression bandaging if indicated and other types of dressings if indicated. Intervention group: Participants receive treatment as usual plus StepIt pedal exercise for 12 weeks or until ulcer healing has taken place. Participants are issued with a StepIt Pedal to use daily for foot and ankle exercises. These exercises consist of resisted plantar flexion while seated, performed 2 times daily in the pattern of: 1 minute exercise / 1 minute rest, 10 times (participants may alternate legs as an alternative to merely resting both legs for 1 minute). The participants will be asked to keep an exercise diary to record their activity. At their discharge visits CONDITION: Specialty: Dermatology, Primary sub‐specialty: Dermatology; UKCRC code/ Disease: Cardiovascular/ Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified ; Skin and Connective Tissue Diseases ; Venous leg ulcers INCLUSION CRITERIA: 1. Over the age of 18 2. VLU* of less than 6 months duration 3. Tolerating compression bandaging 4. Able to give consent *The case definition for VLU is any break in the skin on the lower leg that has been present for 2 weeks or more with a clinical venous aetiology and an ankle brachial pressure of = 0.8 (NICE 2013). PRIMARY OUTCOME: Feasibility outcomes:; 1. Compliance is measured using an assessment of participant diary entries at the end of the trial intervention period at 12 weeks; 2. Recruitment and attrition are measured using final consent numbers and lost at follow‐up numbers at the end of the trial; 3. Adequacy of duration of follow‐up (e.g. in relation to VLU healing) is measured using the number of completely healed ulcers in comparison to the total sample size at the end of week 12; 4. Fitness for purpose of data collection methods including across and between care settings is measured using completion of CRF data at the end of week 12 (comparing data for participants from different care settings and recruitment sites; 5. Adverse events are measured using the total number adverse events recorded at week 12 for all participants SECONDARY OUTCOME: 1. VLU size is measured with Convatec grid tool (outcome measure used for calculating potential power of this present study) at baseline, 6 and 12 weeks; 2. Size and characteristics of VLU, determined with PUSH score at baseline, 6 and 12 weeks; 3. Mobility is measured using the LifeSpace questionnaire score at baseline, 6 and 12 weeks; 4. Ankle range of motion is measured using a goniometer at baseline, 6 and 12 weeks; 5. Ulcer‐related Pain is measured using the VAS pain scale at baseline, 6 and 12 weeks ; 6. Quality of life is measured using the Charing Cross Venous Ulcer Questionnaire at baseline, 6 and 12 weeks; 7. Intervention compliance (StepIt arm patients) is measured using an exercise diary kept by participants throughout the study at the end of week 12; 8. Participant opinion on trial participation is measured using a satisfaction questionnaire at the end of week 12; 9. Patient withdrawal rates due to change in management (e.g. need for surgery) is measured using data on loss to follow‐up at baseline, 6 and 12 weeks; 10. VLU infection rates are measured using clinical record data and microbiology result data at baseline, 6 and 12 weeks