Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

Diabetes Mellitus Foot Ulcer Clinical Trial

Official title:

A Randomised Controlled Trial to Compare Platelet-Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085550
• Other study ID #: 16/LO/2261
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 28, 2019

Study information

• Verified date: October 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 28, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Procedure:
• Fat grafting
Single treatment fat grafting infiltrated into diabetic ulcer wound
• Fat grafting + platelet rich plasma
Single treatment fat grafting mixed with autologous platelet rich plasma infiltrated into diabetic ulcer wound. Autologous PRP is obtained using the ANGEL(TM) Concentrated Platelet Rich Plasma (cPRP) Separation Device which is FDA-regulated and CE certified

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of wound healing	Comparison of rate of wound healing between each group	12 weeks
Primary	Degree of wound healing	Comparison of degree of wound healing (50% and 100% re-epithelialisation)	12 weeks
Secondary	Mechanism of wound healing	Histological analysis of wound biopsies from each group at day 0, week 1 and week 4	12 weeks
Secondary	Health related quality of life	Patient quality of life with each procedure	12 weeks
Secondary	Cost implications	Cost implications of each treatment arm as per NHS coding practice	12 weeks
Secondary	Patient reported outcome measures	Patient reported outcome measures of satisfaction of each procedure	12 weeks