RecruitingACTRN12617000277347

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

Multi site randomised controlled trial comparing clinical effectiveness of electric stimulation therapy compared to or in combination with compression therapy in wound healing of chronic lower leg ulcers (Wound ELECT Trial)

Sponsor

La Trobe University

Enrollment

228 participants

Start Date

May 25, 2017

Study Type

Interventional

Conditions

Chronic venous, lymphoedema and mixed venous/lymphoedema ulcers Lower leg oedema

Summary

The trial will consider the clinical effectiveness of electrical stimulation therapy compared to or in combination with compression therapy. People with a lower leg ulcers will be recruited into the study. Participates will be randomised to either (1) continue their current compression therapy (control). (2) to use electronic stimulation therapy (intervention) or (3) use both compression therapy and electric stimulation. Participants in the study group involving electrical stimulation therapy will use a portable stimulation device that can be self administered in the home setting 4 times a day daily for 20 minutes per session. The number of wounds that heal and the percentage of wound size change will be monitored for 14 weeks in total. Fortnightly for the first follow up visit and then monthly. The clinical effectiveness of the treatments will be considered as will cost effectiveness.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing three approaches for treating leg ulcers caused by poor circulation or lymphedema: compression therapy alone, electrical stimulation therapy alone, or both combined. Participants in the electrical stimulation group use a small portable device at home four times a day. Researchers will track how many wounds heal and how much the wounds shrink over 14 weeks. You may be eligible if: - You are 18 years of age or older - You have a leg ulcer confirmed to be caused by venous disease, lymphedema, or a combination of both - You are suitable for compression therapy - You or a carer can operate the electrical stimulation device You may NOT be eligible if: - You have been diagnosed with Deep Vein Thrombosis (DVT) - You have an implanted cardiac device such as a pacemaker or defibrillator - You are pregnant - You have an active cancer diagnosis - You have a known reaction to adhesives or fragile skin prone to tearing Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.