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Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer

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ClinicalTrials.gov Identifier: NCT03085550
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
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 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 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Foot Ulcer Procedure: Fat grafting Procedure: Fat grafting + platelet rich plasma Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Platelet-Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Conventional dressings management
Experimental: Fat grafting only
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
Single treatment fat grafting infiltrated into diabetic ulcer wound

Experimental: 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
Procedure: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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<7.0);
  • Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%;
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085550


Contacts
Contact: Ash Mosahebi, PhD 020 7794 0500 amosahebi@nhs.net

Locations
United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Neil Hubbard    020 7794 0500 ext 36316    n.hubbard@nhs.net   
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Oliver Smith, MBChB University College, London

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03085550     History of Changes
Other Study ID Numbers: 16/LO/2261
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University College, London:
diabetic foot ulcer
diabetes mellitus
fat grafting
platelet rich plasma
wound healing

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Neuropathies