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.
South Australian Health and Medical Research InstituteDataset description
This dataset includes diabetics (n=30) and non-diabetics (n=11) with minor amputations who had blood samples taken; to identify the association between circulating HDL cholesterol functionality and the rate of wound healing in diabetic and non-diabetic patients. HDL functionality was tested in a series of ex vivo assays established in our laboratory at recruitment (baseline), 1-month and 6-months post-amputation. The parameters tested were HDL cholesterol efflux, anti-inflammatory and pro-angiogenic properties. The file type is .XLS.Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
HDL-DFW2
Trial ID
ACTRN12619001711101
Funding
Charities/Societies/Foundations, The Hospital Research Foundation
Scientific enquiries
Dr Christina Bursill
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 .... Read more
Key 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 .... Read more
Key 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.
Can healthy volunteers participate?
Yes
Population
Sample Size 60
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Diabetic foot ulcer healing
Condition code Metabolic and Endocrine , Skin
Intervention
Intervention code Not applicable
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 digita .... Read more
Comparison
Control group Active
We are using a healthy age-matched control group that have no wounds and are non-diabetic. A single blood sample will be taken from this cohort and HDL cholesterol levels and functionality will be assessed and compared to the diabetic and non-diabetic wound cohorts
Outcomes
Outcome: Percentage wound closure from baseline wound area as measured using a 3D camera and digital planimetry. Timepoint: Sixteen weeks post- minor amputation
Outcome: HDL cholesterol levels at the time of minor ampuation (baseline) as measured in the plasma using standard laboratory kits. Timepoint: At the time of minor amputation (baseline)
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Clinical data only (not personal data)
When will data be available?
The data will be made available after publication of the manuscript of this work. The data will be available for a period of 15 years.
Available to whom?
To people in the medical research community who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Wound healing meta analyses