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Completed

NCT Number: NCT03085550

Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

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.

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Key information

Conditions

Diabetes Mellitus Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hospital

London, NW3 2QG, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fat Grafting

Procedure

Single treatment fat grafting infiltrated into diabetic ulcer wound

Fat grafting + platelet rich plasma

Procedure

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

Primary outcomes

  1. Rate of wound healing

    Time frame: 12 weeks

    Comparison of rate of wound healing between each group

  2. Degree of wound healing

    Time frame: 12 weeks

    Comparison of degree of wound healing (50% and 100% re-epithelialisation)

Secondary outcomes

  1. Mechanism of wound healing

    Time frame: 12 weeks

    Histological analysis of wound biopsies from each group at day 0, week 1 and week 4

  2. Health related quality of life

    Time frame: 12 weeks

    Patient quality of life with each procedure

  3. Cost implications

    Time frame: 12 weeks

    Cost implications of each treatment arm as per NHS coding practice

  4. Patient reported outcome measures

    Time frame: 12 weeks

    Patient reported outcome measures of satisfaction of each procedure

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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