Fat grafting and platelet‐rich plasma for the treatment of diabetic foot ulcers: A feasibility‐randomised controlled trial

Abstract

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 http://clinicaltrials.gov. Registered 01/03/2017.

Autologous Stem Cell Therapy for Chronic Lower Extremity Wounds: A Meta-Analysis of Randomized Controlled Trials

“…Concisely, a total of 716 studies were identified in the initial database search; 543 articles were excluded because they were not relevant to our study’s objective, according to our screening process outlined in Figure 1 . Among the 173 potentially relevant studies, 28 RCTs matched the inclusion criteria for the current meta-analysis [ 15 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. There were 146 studies further excluded: 106 studies were not RCTs, 19 studies did not use ASCT, 6 studies were non-human trials, 3 studies did not include lower extremity wounds, 4 studies used control groups that did not receive standard treatment with or without sham injections, and 8 studies were not retrievable full-length articles.…”

“…With 304 patients treated with the ASCT and 323 patients assigned to the control groups, we investigated the effects of ASCT on the healing of LECWs ( Figure 2 A). Complete wound healing was defined as 100% re-epithelialization as judged by the treating podiatrist and clinician, with no need for further dressing therapy [ 47 ]. Overall, the results indicated that ASCT was associated with a significant increase in the complete wound healing rate as compared with that observed in the control groups.…”

Current art of combination therapy with autologous platelet‐rich plasma for stable vitiligo: A meta‐analysis

“…Potential favourable effects of leucocytes may be attributed to their roles in tissue remodelling, antibacterial affects, and regulation of immune responses 35 . Topical application or intradermal injection of PRP allow biomolecules to be delivered to target tissues, which effectively regulate some essential functions in the local microenvironment: proliferation, migration, and differentiation of stem cells (eg, dermal fibroblasts, epithelial cells, and endothelial cells), new collagen and matrix formation, modulation of inflammatory and immune responses, and angiogenesis, as well as antimicrobial effects 5,36‐40 . These healing and regenerative properties pave the way that PRP may be a potentially effective biomaterial in vitiligo treatment.…”

“…35 Topical application or intradermal injection of PRP allow biomolecules to be delivered to target tissues, which effectively regulate some essential functions in the local microenvironment: proliferation, migration, and differentiation of stem cells (eg, dermal fibroblasts, epithelial cells, and endothelial cells), new collagen and matrix formation, modulation of inflammatory and immune responses, and angiogenesis, as well as antimicrobial effects. 5,[36][37][38][39][40] These healing and regenerative properties pave the way that PRP may be a potentially effective biomaterial in vitiligo treatment. Recently, some researchers have begun to combine PRP with several conventional treatments for vitiligo in comparison to monotherapy, but inconsistent results were reported.…”

Histological analysis of fat grafting with platelet‐rich plasma for diabetic foot ulcers—A randomised controlled trial

“…A prospective, human randomised single‐centre feasibility study was undertaken 39 . This was a three‐armed study comparing fat grafting, fat grafting with PRP, and routine care for the treatment of diabetic foot ulcers.…”