An Evaluation of the association between High Density Lipoprotein (HDL) levels and functionality with the rate of wound healing in diabetic and non-diabetic patients.
- Conditions
- Diabetic foot ulcer healingSkin - Normal skin development and functionMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12619001711101
- Lead Sponsor
- The University of Adelaide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Consenting men and non-pregnant women. For diabetic patients: (Type I and II), HbA1c<12%, eGFR >15 mL/min/1.73m2 and not on dialysis with recent ray amputation. For non-diabetic patients: recent ulcer on the forefoot and on the dorsal side. For both diabetic and non-diabetic patients: no signs of active infection and evidence of adequate perfusion (>40 mm/Hg toe cuff pressure). Lipid drugs (e.g. statins, ezetimibe) are allowed. For healthly donor controls must be age-matched and be non-diabetic with no ulcers.
Elevated liver enzymes (>50 units AST, >56 units ALT), stroke or transient ischaemic attack within 3 months, heart failure, cancer with ongoing treatment or prognosis of <5 years, active inflammation, history of pancreatitis, DVT or pulmonary embolism, organ transplant, steroid therapy, hyperbaric treatment, dialysis, wound vacuum therapy, no history of Parkinson’s disease. Not deemed likely to require major leg amputation within 4 weeks or any obstacle to regular follow-up.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage wound closure from baseline wound area as measured using a 3D camera and digital planimetry. [Sixteen weeks post- minor amputation];HDL cholesterol levels at the time of minor ampuation (baseline) as measured in the plasma using standard laboratory kits. [At the time of minor amputation (baseline)]
- Secondary Outcome Measures
Name Time Method