Clinical Treatment of Acute and Chronic Wounds using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate
Phase 1
- Conditions
- Chronic venous ulcerSkin - Other skin conditionsCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12613001332718
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Male or female, aged >18 years
-Venous ulceration for longer than 4 weeks between the knee and malleoli
-Ulcer size <10cm2
-Ankle brachial pressure index of 0.85 or greater
-superficial or deep venous reflux on duplex scanning.
Exclusion Criteria
-duplex scanning not possible
-multilayer compression therapy not practical
-those who are unable or unwilling to give informed consent
-those with deep venous occlusion
-those unfit for local anaesthetic and sedation
-those with malignant ulceration.
-infection, cellulitis, or osteomyelitis in the affected leg diagnosed by MRI and microbiologic culture results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All patients will be reviewed at weekly intervals to assess clinical progress in the Plastics outpatients clinic. A Registered Nurse who is blinded to the treatment group will perform assessment. <br>Clinical photography<br>Digital measurement of ulcer size using Visitrak (Smith & Nephew) <br>Clinical assessment of any complications such as infection. <br><br>The primary outcome measure will be ulcer healing. Ulcer healing was defined as complete re-epithelialisation of the leg. <br>[Assessed weekly until the ulcer has healed]
- Secondary Outcome Measures
Name Time Method infection - clinical assessment, microbiology, blood tests[Assessed weekly until the ulcer has healed]