PMID- 32633854
OWN - NLM
STAT- MEDLINE
DCOM- 20210806
LR  - 20210806
IS  - 1742-481X (Electronic)
IS  - 1742-4801 (Print)
IS  - 1742-4801 (Linking)
VI  - 17
IP  - 6
DP  - 2020 Dec
TI  - Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: 
      A feasibility-randomised controlled trial.
PG  - 1578-1594
LID - 10.1111/iwj.13433 [doi]
AB  - Chronic, nonhealing diabetic foot ulcers (DFU) are increasing in prevalence and 
      are often unresponsive to conventional therapy. Adipose tissue, containing 
      adipose-derived stem cells, and platelet rich plasma (PRP) are regenerative 
      therapies rich in growth factors which may provide a solution to chronic wound 
      healing. This study aimed to assess the feasibility of conducting a definitive 
      randomised controlled trial (RCT) to investigate the efficacy of these therapies 
      for the treatment of DFU. This was a single centre, feasibility, three-arm, 
      parallel group RCT. Eligible DFU patients were randomised on a 1:1:1 basis to 
      three intervention arms: control (podiatry); fat grafting; fat grafting with PRP. 
      The intervention was delivered once and patients were followed-up for 12 weeks. 
      The primary objective was to assess measures of trial feasibility. Clinical 
      outcomes and health-related quality of life (HRQoL) were also evaluated. Three 
      hundred and thirty four patients were screened and 32 patients (9.6%) were deemed 
      eligible with 18 enrolled in the trial (6 per arm) over 17 months. All 
      participants completed the trial with no withdrawals or crossover. Participant 
      engagement was high with most HRQoL questionnaires returned and only 4.8% 
      follow-up appointments missed. There were five adverse events (AEs) related to 
      the trial with no serious AEs. Five (28%) of the wounds healed. There was no 
      difference between any of the groups in terms of clinical outcomes. This 
      feasibility study demonstrated that a multi-centre RCT is safe and feasible with 
      excellent patient engagement. We have highlighted crucial information regarding 
      methodology and recruitment, which will guide future trial design. Registration 
      number: NCT03085550 clinicaltrials.gov. Registered 01/03/2017.
CI  - (c) 2020 Medicalhelplines.com Inc and John Wiley & Sons Ltd.
FAU - Smith, Oliver J
AU  - Smith OJ
AUID- ORCID: 0000-0002-3290-7366
AD  - Department of Plastic Surgery, Royal Free Hospital, London, UK.
AD  - Division of Surgery and Interventional Science, University College London, 
      London, UK.
FAU - Leigh, Richard
AU  - Leigh R
AD  - Department of Podiatry, Royal Free Hospital, London, UK.
FAU - Kanapathy, Muholan
AU  - Kanapathy M
AUID- ORCID: 0000-0002-5311-8833
AD  - Department of Plastic Surgery, Royal Free Hospital, London, UK.
FAU - Macneal, Peter
AU  - Macneal P
AD  - Department of Plastic Surgery, St George's Hospital, London, UK.
FAU - Jell, Gavin
AU  - Jell G
AD  - Division of Surgery and Interventional Science, University College London, 
      London, UK.
FAU - Hachach-Haram, Nadine
AU  - Hachach-Haram N
AD  - Department of Plastic Surgery, Royal Free Hospital, London, UK.
FAU - Mann, Haroon
AU  - Mann H
AD  - Department of Trauma and Orthopaedics, Royal Free Hospital, London, UK.
FAU - Mosahebi, Ash
AU  - Mosahebi A
AD  - Department of Plastic Surgery, Royal Free Hospital, London, UK.
AD  - Division of Surgery and Interventional Science, University College London, 
      London, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT03085550
GR  - BAPRAS/
GR  - National Institute for Health Research/
GR  - British Association of Plastic, Reconstructive and Aesthetic Surgeons/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200707
PL  - England
TA  - Int Wound J
JT  - International wound journal
JID - 101230907
SB  - IM
MH  - Adipose Tissue/*transplantation
MH  - Adult
MH  - Aged
MH  - *Diabetes Mellitus
MH  - *Diabetic Foot/therapy
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Platelet-Rich Plasma
PMC - PMC7949265
OTO - NOTNLM
OT  - diabetic foot ulcers
OT  - fat grafting
OT  - platelet rich plasma
OT  - wound healing
COIS- The authors declare no potential conflict of interest.
EDAT- 2020/07/08 06:00
MHDA- 2021/08/07 06:00
PMCR- 2020/07/07
CRDT- 2020/07/08 06:00
PHST- 2020/04/17 00:00 [received]
PHST- 2020/05/30 00:00 [revised]
PHST- 2020/06/02 00:00 [accepted]
PHST- 2020/07/08 06:00 [pubmed]
PHST- 2021/08/07 06:00 [medline]
PHST- 2020/07/08 06:00 [entrez]
PHST- 2020/07/07 00:00 [pmc-release]
AID - IWJ13433 [pii]
AID - 10.1111/iwj.13433 [doi]
PST - ppublish
SO  - Int Wound J. 2020 Dec;17(6):1578-1594. doi: 10.1111/iwj.13433. Epub 2020 Jul 7.