Clinical trial NCT03085550: Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Official title: A Randomised Controlled Trial to Compare Platelet-Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Foot Ulcer
Keywords: diabetic foot ulcer
diabetes mellitus
fat grafting
platelet rich plasma
wound healing
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing properties through releasing pro-healing factors and regulating angiogenesis. When used combination there is evidence of additional wound healing benefits.

The aim is to investigate the feasibility of conducting a randomised controlled trial with fat grafting and fat/PRP co-grafting as interventions for diabetic ulcers. We aim to develop pilot data which can power a multi-centre study. The aim of the trial would be to determine the feasibility of the trial by assessing recruitment, randomisation and retention of participants. We would also evaluate the rate of wound healing in diabetic ulcers when treated with conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will be to understand the mechanism of the healing process, the health related quality of life and patient satisfaction and the cost implications.

The study is a single-blinded randomised controlled trial of approximately 30 patients with three parallel treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and will undergo subsequent histological analysis to evaluate the mechanism of healing. The study is expected to last two years from recruitment of the first patient and will be conducted at Royal Free Hospital and UCL Division of Surgery and Interventional Science.

The combination of fat+PRP may provide diabetic patients the option of a single treatment with improved healing, shorter followup and a reduced cost burden. Validation of the mechanism of healing through histological analysis will confirm clinical findings and help guide future research.

Detailed description: RCT to compare fat grafting and fat grafting with PRP in chronic diabetic wounds.

Eligibility criteria: Inclusion Criteria:

* Male or female;
* Age 18-90 at the time of consent;
* Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and less than 10cm x 10cm;
* Wound with clean, healthy granulating bed, with minimal adherent slough;
* Patient understands and is willing to participate and can comply with weekly visits and follow-up regime.

Exclusion Criteria:

* Wound with active infection;
* Patients with underlying vascular insufficiency (ABPI\<0.3);
* Uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 90mmol/mol;
* Presence of one or more medical conditions, including renal, hepatic, haematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study;
* Patient not fit for surgery (ASA classification \> 4).

Primary outcomes:
measure: Rate of wound healing
timeFrame: 12 weeks
measure: Degree of wound healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Mechanism of wound healing
timeFrame: 12 weeks
measure: Health related quality of life
timeFrame: 12 weeks
measure: Cost implications
timeFrame: 12 weeks
measure: Patient reported outcome measures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: University College, London
name: Oliver Smith, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan GS, Smith OJ, Heavey S, Jell G, Mosahebi A. Histological analysis of fat grafting with platelet-rich plasma for diabetic foot ulcers-A randomised controlled trial. Int Wound J. 2022 Feb;19(2):389-398. doi: 10.1111/iwj.13640. Epub 2021 Jun 24.
citation: Smith OJ, Leigh R, Kanapathy M, Macneal P, Jell G, Hachach-Haram N, Mann H, Mosahebi A. Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: A feasibility-randomised controlled trial. Int Wound J. 2020 Dec;17(6):1578-1594. doi: 10.1111/iwj.13433. Epub 2020 Jul 7.