A Prospective randomised controlled trial of low-frequency ultrasound debridement (LFUD) for lower limb wounds
Not Applicable
- Conditions
- Chronic Venous insufficiencyLower Limb UlcersCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemSurgery - Surgical techniques
- Registration Number
- ACTRN12624000949583
- Lead Sponsor
- niversity of Otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Male and female adults with lower limb wounds requiring debridement.
Exclusion Criteria
Participants were excluded if they were not able to attend follow-up, or if a biopsy confirmed skin malignancy or vasculitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in wound size (area)[wound area was measured by a dedicated vascular nurse on the epithelialised area of the index ulcer using a digital camera (SilhoueteStar Aranz Medical,Christchrch, NZ). Measurements were taken via image capture on week 4, 8, 12, 24, and 52. Epithelial boundaries were electronically drawn using the associated software (SilhoutteConnect® Aranz Medical, Christchurch, NZ), calculating the non-epithelialised area based on the boundaries drawn. baseline, and weeks 4, 8, 12, 24 (primary endpoint) and 52 post-intervention commencement]
- Secondary Outcome Measures
Name Time Method