Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

NCT03085550 | Completed

• 1 other identifier: 16/LO/2261
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Foot Ulcer

Keywords

diabetic foot ulcer; diabetes mellitus; fat grafting; platelet rich plasma; wound healing

Outcome Measures

Primary Outcomes (2)

• Rate of wound healing

  Comparison of rate of wound healing between each group

  12 weeks

• Degree of wound healing

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

  12 weeks

Secondary Outcomes (4)

• Mechanism of wound healing

  12 weeks

• Health related quality of life

  12 weeks

• Cost implications

  12 weeks

• Patient reported outcome measures

  12 weeks

Study Arms (3)

Control

NO INTERVENTION

Conventional dressings management

Fat grafting only

EXPERIMENTAL

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

Procedure: Fat grafting

Fat grafting + Platelet rich plasma

EXPERIMENTAL

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

Procedure: Fat grafting + platelet rich plasma

Interventions

Fat grafting PROCEDURE

Single treatment fat grafting infiltrated into diabetic ulcer wound

Fat grafting only

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

Fat grafting + Platelet rich plasma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34169656 DERIVED

• 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.

  PMID: 32633854 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Oliver Smith, MBChB

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 21, 2017
• Study Start: February 1, 2018
• Primary Completion: July 2, 2019
• Study Completion: October 28, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

GB (1)