Evaluation of the effects of the Good Cholesterol on Wound Healing

Phase 1

• Conditions: Diabetic Foot Ulcer; Impaired wound healing; Skin - Other skin conditions; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000269134
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Consenting men and non-pregnant women with diabetes (Type I and II), HbA1c<12%, eGFR >15 mL/min/1.73m2 and not on dialysis. Recent ray amputation (24-48 h) with no signs of active infection and evidence of adequate perfusion (>40 mm/Hg toe cuff pressure). Lipid drugs (e.g. statins, ezetimibe) are allowed.

Exclusion Criteria

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: Interventional
• Study Design: Not specified