Fat grafting and platelet-rich plasma for the treatment of diabetic foot ulcers: A feasibility-randomised controlled trial.
diabetic foot ulcers
fat grafting
platelet rich plasma
wound healing
Journal
International wound journal
ISSN: 1742-481X
Titre abrégé: Int Wound J
Pays: England
ID NLM: 101230907
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
17
04
2020
revised:
30
05
2020
accepted:
02
06
2020
pubmed:
8
7
2020
medline:
7
8
2021
entrez:
8
7
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 32633854
doi: 10.1111/iwj.13433
pmc: PMC7949265
doi:
Banques de données
ClinicalTrials.gov
['NCT03085550']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1578-1594Subventions
Organisme : BAPRAS
Organisme : National Institute for Health Research
Organisme : British Association of Plastic, Reconstructive and Aesthetic Surgeons
Informations de copyright
© 2020 Medicalhelplines.com Inc and John Wiley & Sons Ltd.
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