Not Yet RecruitingPhase 2ACTRN12619000269134

Evaluation of the effects of the Good Cholesterol on Wound Healing

Evaluation of the topical application of High-Density Lipoproteins on wound healing in patients with Diabetic Foot Ulcers

Sponsor

University of Adelaide

Enrollment

142 participants

Start Date

Apr 1, 2019

Study Type

Interventional

Conditions

Impaired wound healing Diabetic Foot Ulcer

Summary

This study will test the efficacy of topically applied rHDL to acute wounds of patients that have just had a ray amputation (removal of toe(s)) due to diabetes-related necrosis. They will receive rHDL three times a week for 6 weeks. Follow up will be for a total of 12 months.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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 Criteria1

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

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Interventions

Reconstituted High-density lipoproteins (rHDL) will be applied topically three days a week for 6 weeks. The treatments will be applied by a wound care nurse or podiatrist on the study who will make h

Reconstituted High-density lipoproteins (rHDL) will be applied topically three days a week for 6 weeks. The treatments will be applied by a wound care nurse or podiatrist on the study who will make home visits and also attend clinic visits. This will ensure adherence to the intervention. The rHDL will be applied in the first 24-72h post-minor amputation after inspection to make sure that the new wound bed is free of infection.