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.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001711101

Acronym

HDL-DFW2

Enrollment

Registered

2019-12-04

Start date

2020-02-24

Completion date

2021-02-22

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Diabetes affects nearly one million Australians. In more than 80% of diabetics who develop foot ulcers, poor wound healing results in the need for lower limb amputation. There is currently no treatment available for wound healing. This study aims to identify whether there is an association between circulating HDL cholesterol levels and the rate of wound healing in diabetic and non-diabetic patients. Over the last five years it has become evident that the functionality of the HDL particle is more predictive of disease outcome than HDL cholesterol levels. We will therefore also test HDL functionality is a series of ex vivo assays established in our laboratory. This study seeks to understand the relationship between HDL and wound healing in diabetes.

Interventions

This study will determine the association between circulating HDL cholesterol levels and functionality and the rate of wound closure in diabetic and non-diabetic patients. Blood samples (20 mL) will be taken at the time of recruitment (baseline) then at 2 weeks, 6 weeks, 6 months and 12 months post-amputation (5 blood samples in total/participant). Wound biopsies (3mm2) will be collected at the time of amputation and then 4 weeks post-ampuation. Changes in wound area using a 3D camera and digit

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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.

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.

Outcome results