None listed
Conditions
Brief 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.
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
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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
*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.
Outcome results
None listed