Non-inferiority randomised controlled trial comparing wound healing with compression therapy to electric stimulation therapy (Wound ELECT Trial)

INTERVENTION: An electric stimulation therapy—Bodyflow (Trademark) Therapy—involves the application of electrodes to the limb which delivers a mild transdermal electrical stimulus targeting stimulation of smooth muscle (Tunica media) to promote the stimulation of arterial, venous and lymphatic systems. Participants will be randomly allocated to one of three treatment groups in total n = 208 participants will be required. 1 Compression therapy (control) n=69 2 Electric Stimulation Therapy (with no compression therapy) n=69 3 Electric Stimulation Therapy and compression therapy n=69 The Bodyflow (Trademark) Electric Stimulation Device is a small portable device suitable for self‐administration in the home setting. Recruits to the Bodyflow group will be given a demonstration on the use of Bodyflow by the clinician on recruitment including the placement of the electrodes, management of the battery powered unit. Written instruction are also given to the recruits to reinforce the instructions on the operation of the device. For recruits in the compression and electrical stimulation group, compression is not removed during treatment. Guidelines for utilising the Bodyflow (Trademark) Therapy is four times daily for 20 minute sessions over 14 weeks, implemented by the participant or an informal carer in the home environment. Electrodes are attached to the lower limb around the wound (not directly over it) or above or below compression therapy if institu. The device is pre‐set to a single, non‐adjustable specific low frequency found between one and two Hertz, a current that specifically targets smooth muscle. Use of the device can create a pulsing or tingling sensation. There are no reported serious adverse events anticipated from the use of the Bodyflow (Trademark) Therapy. Adherence to treatment in the Bodyflow group will be automatically logged by the machine. Continuing and ongoing data collection tools will be completed on each assessment visit and subsequent 2 week visit, 6 week visit, 10 week visit and 14 week visit. CONDITION: Chronic venous, lymphoedema and mixed venous/lymphoedema ulcers Lower leg oedema PRIMARY OUTCOME: Healed Study wound defined as 100% epithelization/wound closure . ; Wound will be traced and measured using ImageJ is a public domain electronic Java image processing and analysis program. SECONDARY OUTCOME: Secondary outcome 1 ; Wound healing algorithms to assess‐ Percentage of area change (PAC) for the ‘study wound. (determined from wound planimetry methods and corroborated by digital image planimetry. ; Secondary Outcome 2 ; Limb measurements recorded by measuring the leg in centimetres from smallest ankle measure to the widest calf measure and the big toe distal to web space. Secondary Outcome 3 ; Adherence to four daily (20 minute) treatments with Electric Stimulation Therapy as automatically recorded by the device during use. Self‐reported adherence will be further recorded by participants in a log stored with the Electric Stimulation Therapy device. Secondary Outcome 4 ; Indicative cost indicators will be measured over the duration of the recruits participation in the study. INCLUSION CRITERIA: *A person is eligible if they are over 18 years and have a leg ulcer with a confirmed diagnosis of venous, lymphodema or venous/lymphodema ulcer. *A person is appropriate for best practice treatment (compression therapy). *The person or carer /guardian is able to provide informed consent