Platelet Rich Plasma and Autologous Fat Graft for Diabetic Ulcer
Condition: Diabetes Mellitus Foot Ulcer
MeSH terms: Foot Ulcer; Diabetes Mellitus; Ulcer
Study type: Interventional

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.
    

Intervention name(s): Fat grafting; Fat grafting + platelet rich plasma
Intervention type(s): Procedure; Procedure
Intervention description(s): Single treatment fat grafting infiltrated into diabetic ulcer wound; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic foot ulcer; diabetes mellitus; fat grafting; platelet rich plasma; wound healing