ACTRN12614000249651
Not yet recruiting
Phase 2
A single blinded randomised controlled trial to determine the clinical effect size and client concordance following eight weeks using a portable electrostimulation device among people with an active leg ulcer who do not tolerate moderate to high compression therapy
BodyFlow International Pty Ltd0 sites30 target enrollmentMarch 10, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Venous leg ulcers
- Sponsor
- BodyFlow International Pty Ltd
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Client has an existing leg ulcer with either primary venous or lymphedema as its primary aetiology
- •2\. Client is appropriate for, and the best practice treatment would involve the highest compression therapy available (\+40mmHg)
- •3\. Client is currently using (1\) no compression therapy or (2\) low compression therapy (less than 18mmHg)
- •4\. Client has received wound care education specifically promoting the use of compression therapy
- •5\. The client or carer/legal guardian is able to provide informed consent to participate in the study
- •6\. Client has had a Doppler ultrasound in the last 12 weeks
- •7\. Ankle Pressure Brachial Index is between greater than or equal to 0\.8 and less than or equal to 1\.2
Exclusion Criteria
- •1\. Client is using moderate or high compression therapy (equal to or greater than 18mmHg) for any period of the day for one or more days of the week.
- •2\. Client is unable to or does not have someone who can physically implement the Electrostimulation Therapy.
- •3\. Client is unable to or does not have someone who can take low compression garments (for those currently wearing compression) on and off in between Electrostimulation Therapy treatments
- •4\. Client has an existing diagnosis of Deep Vein Thrombosis (DVT)
- •5\. Client has an implanted cardiac device such as a permanent pace\-maker or internal defibrillator
- •6\. Diagnosed with an active malignant disease
- •7\. Client is pregnant
- •8\. Client has signs of clinical infection in their ulcer
- •9\. Client has a known reaction to adhesive chemicals such as those used on dressings
- •10\. Client is assessed by their clinician as having fragile skin that is at risk of damage when removing the adhesive pads
Outcomes
Primary Outcomes
Not specified
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