Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

Not Applicable

Completed

• Conditions: Diabetes Mellitus Foot Ulcer
• Interventions: Procedure: Fat grafting; Procedure: Fat grafting + platelet rich plasma

• Registration Number: NCT03085550
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2018-02-01
• Primary Completion: 2019-07-02
• Study Completion: 2019-10-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fat grafting only	Fat grafting	Patients will undergo conventional fat harvesting as per Coleman technique and infiltration of fat into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio
Fat grafting + Platelet rich plasma	Fat grafting + platelet rich plasma	Patients will undergo conventional fat harvesting as per Coleman technique. Fat will be mixed with autologous PRP and infiltrated into diabetic ulcer wound bed in 1cc:10cm2 fat:wound size ratio

Primary Outcome Measures

Name	Time	Method
Rate of wound healing	12 weeks	Comparison of rate of wound healing between each group
Degree of wound healing	12 weeks	Comparison of degree of wound healing (50% and 100% re-epithelialisation)

Secondary Outcome Measures

Name	Time	Method
Mechanism of wound healing	12 weeks	Histological analysis of wound biopsies from each group at day 0, week 1 and week 4
Health related quality of life	12 weeks	Patient quality of life with each procedure
Cost implications	12 weeks	Cost implications of each treatment arm as per NHS coding practice
Patient reported outcome measures	12 weeks	Patient reported outcome measures of satisfaction of each procedure

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom