An exploratory clinical trial of Autologous Platelet Gel (APG) in adults with Venous Leg Ulcers (VLU).
Not Applicable
Withdrawn
- Conditions
- Venous Leg UlcerCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemSkin - Other skin conditions
- Registration Number
- ACTRN12616001292460
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Eligible participants will be aged over 18 years and have a chronic VLU (target ulcer) that has been present for more than 4 weeks with no improvement. Participants must have an ABPI greater than or equal to 0.7 mmHg to exclude significant arterial insufficiency. The eligible target ulcer will have an area greater than or equal to 1 cm2 to less than or equal to 40 cm2 as measured by acetate tracing grid techniques (largest ulcer on limb and separated from other ulcers by at least 1 cm). If more than one leg ulcer is present, the largest ulcer will be treated.
Exclusion Criteria
Participants who have severe liver, cardiac or pulmonary disease or known current malignancy will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method