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

Inclusion Criteria3

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

Exclusion Criteria7

Person is unable to or does not have an informal carer/support person able to physically implement the Electric Stimulation Therapy
Person has an an existing diagnosis of Deep Vein Thrombosis (DVT)
Person has an implanted cardiac device such as a permanent pace-maker or internal defibrillator.
Pregnant women
Person with a diagnosis of an active malignant disease
Person with a known reaction to adhesives
Person who is assessed by the attending clinician to be at risk of skin tears upon removal of the adhesive pads as part of the electric stimulation device due to fragile skin.

Interested in this trial?

Get notified about updates and connect with the research team.

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.