on-inferiority randomised controlled trial comparing wound healing with compression therapy to electric stimulation therapy (Wound ELECT Trial)
- Conditions
- Chronic venous, lymphoedema and mixed venous/lymphoedema ulcersLower leg oedemaSkin - Other skin conditionsCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12617000277347
- Lead Sponsor
- a Trobe University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 228
*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
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healed Study wound defined as 100% epithelization/wound closure .<br>Wound will be traced and measured using ImageJ is a public domain electronic Java image processing and analysis program.[From screening and recruitment recruits will be monitored at 2 weeks, 6 weeks, 10 weeks and 14 weeks. ]
- Secondary Outcome Measures
Name Time Method