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Trial registered on ANZCTR


Registration number
ACTRN12619000269134
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
21/02/2019
Date last updated
21/02/2019
Date data sharing statement initially provided
21/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effects of the Good Cholesterol on Wound Healing
Scientific title
Evaluation of the topical application of High-Density Lipoproteins on wound healing in patients with Diabetic Foot Ulcers
Secondary ID [1] 293851 0
NIL
Universal Trial Number (UTN)
U1111-1208-2753
Trial acronym
HDL-DFW
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 306314 0
Impaired wound healing 306315 0
Condition category
Condition code
Skin 305400 305400 0 0
Other skin conditions
Metabolic and Endocrine 310286 310286 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313707 0
Treatment: Drugs
Comparator / control treatment
Saline (vehicle) will be the control for this experiment
Control group
Placebo

Outcomes
Primary outcome [1] 319145 0
Primary Outcome: Percentage wound closure from baseline wound area as measured using the 'Wound Vue" 3D camera and wound tracings onto sterile transparent film.

Timepoint [1] 319145 0
16 weeks post-minor amputation.
Secondary outcome [1] 367119 0
Amputation free survival as assessed by record keeping during the follow up visits over a 12 month period
Timepoint [1] 367119 0
12 months post-minor amputation in which the follow-up frequency will be monthly for 6 months, with a final visit 12 months post-minor amputation.
Secondary outcome [2] 367120 0
Time to complete wound closure as measured using the 'Wound Vue" 3D camera and wound tracings onto sterile transparent film.
Timepoint [2] 367120 0
Assessed weekly for the first 16 weeks and then monthly for two more months with a final 12 month visit post-minor amputation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - The person who recruits the patient will not be aware of what treatment the patient will receive. Allocation will involve contacting the holder of the allocation schedule who will be located off-site that there is an eligible patient for the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Study power: Based on a wound healing trial in the Lancet, we predict complete wound closure (area 0cm2) in 50% of the rHDL treatment group, with less wound closure in the placebo group (remaining wound area ~3cm2) at 16 weeks. A total of 128 subjects (64/group) will give 80% power to detect a difference of 3cm2 with SD=6cm2 at 5% significance level using a two-sided t-test. Accounting for non-compliance/losses-to-follow-up of 10%, we aim to recruit 142 subjects (71/group). In the experience of Principal Investigator Prof Robert Fitridge, >90% continue clinic attendance after amputation.

Statistics: Comparisons between groups will use two-tailed t-tests or one-way ANOVA with post hoc analyses for pairwise comparisons (Newman-Keuls multiple comparison) using SAS software. Adjusted analyses over time will use Generalised Linear Modelling. Statistical inferences will be drawn at 2P<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13188 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 13189 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 25743 0
5000 - Adelaide
Recruitment postcode(s) [2] 25744 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 298473 0
Charities/Societies/Foundations
Name [1] 298473 0
Hospital Research Foundation
Address [1] 298473 0
60 Woodville Road, Woodville South Australia 5011
Country [1] 298473 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 301819 0
None
Name [1] 301819 0
Address [1] 301819 0
Country [1] 301819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299460 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 299460 0
Citi Centre Building 11 Hindmarsh Square Adelaide South Australia 5000
Ethics committee country [1] 299460 0
Australia
Date submitted for ethics approval [1] 299460 0
22/01/2018
Approval date [1] 299460 0
01/02/2019
Ethics approval number [1] 299460 0
HREC/18/CALHN/107

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80478 0
Prof Robert Fitridge
Address 80478 0
Royal Adelaide Hospital
Department of Vascular Surgery
North Terrace
Adelaide
South Australia, 5000
Country 80478 0
Australia
Phone 80478 0
+61 0439800583
Fax 80478 0
Email 80478 0
Robert.fitridge@adelaide.edu.au
Contact person for public queries
Name 80479 0
Dr Christina Bursill
Address 80479 0
South Australian Health and Medical Research Institute
Level 6, Heart Health Theme
North Terrace
Adelaide
South Australia, 5000
Country 80479 0
Australia
Phone 80479 0
+61 0409677846
Fax 80479 0
Email 80479 0
Christina.Bursill@sahmri.com
Contact person for scientific queries
Name 80480 0
Dr Christina Bursill
Address 80480 0
South Australian Health and Medical Research Institute
Level 6, Heart Health Theme
North Terrace
Adelaide
South Australia, 5000
Country 80480 0
Australia
Phone 80480 0
+61 0409677846
Fax 80480 0
Email 80480 0
Christina.Bursill@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
IPD will be available immediately following publication and with no end date to the availability of the IPD.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose - for example for IPD meta-analyses,
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results