None listed
Conditions
Brief 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.
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 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.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed