PREVUE
Research type
Research Study
Full title
PREVUE; PlantaR flexion Exercise for Venous Ulcer Evaluation, a multi-centre, controlled, prospective, randomized trial
IRAS ID
222694
Contact name
Leon Jonker
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Venous leg ulcers (VLUs) are the most common type of leg ulcers, affecting 1-3% of the population over 60 years and this incidence is expected to increase with an aging population. There is some evidence to suggest that specific exercise of the calf muscle through for example plantar flexion movement with resistance – moving the front of the foot up and down, similar to what a drummer does when using the foot pedal of a drum - may improve the calf muscle pump function. The positive effects have been shown haemodynamically; they have shown that at least in the short-term there is better blood flow and endurance if the calf muscle is exercised in this manner. As yet there remains considerable uncertainty as to the effects of an exercise programme on ulcer healing. This study is a prospective, controlled, randomised, feasibility trial to determine if the use of a CE-approved plantar flexion pedal, developed by StepIt Ltd, will be of benefit to people with VLU in terms of healing rate of VLUs. This pilot aims to assess the feasibility of conducting a full randomised clinical trial in the future. Of the total of 48 patients to be recruited, 24 patients will be randomised to treatment as usual, standard compression therapy only, and the other 24 will be allocated to treatment as usual plus a StepIt exercise programme for 12 weeks. The main outcome measure will be the degree of healing of the VLU. Other outcomes measures will include acceptability of the device training, trial completion rates, and ankle range of motion. Patients with VLUs are less mobile than their aged matched population for a variety of reasons. Initiating foot and ankle exercises may be a first step in increasing physical activity for this population and improving calf muscle pump function.
REC name
Wales REC 1
REC reference
17/WA/0103
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion