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

2020 ◽  
Vol 17 (6) ◽  
pp. 1578-1594
Author(s):  
Oliver J. Smith ◽  
Richard Leigh ◽  
Muholan Kanapathy ◽  
Peter Macneal ◽  
Gavin Jell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Foot ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Fat Grafting ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Frances Game ◽  
William Jeffcoate ◽  
Lise Tarnow ◽  
Florence Day ◽  
Deborah Fitzsimmons ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Randomised Controlled

The Leucopatch®System in the Management of Hard-to-Heal Diabetic Foot Ulcers—A Multicentre, Multinational, Observer-Blinded, Randomised Controlled Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 638-P
Author(s):  
FRANCES GAME ◽  
WILLIAM JEFFCOATE ◽  
LISE TARNOW ◽  
JUDITH L. JACOBSEN ◽  
DIANE J. WHITHAM ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Randomised Controlled

Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial

2021 ◽  
Vol 30 (Sup7) ◽  
pp. S18-S27
Author(s):  
John C Lantis ◽  
Robert Snyder ◽  
Alexander M Reyzelman ◽  
Carl C Van Gils ◽  
Felix Sigal ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Wound Closure ◽  
Controlled Trial ◽  
Acellular Dermal Matrix ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Dermal Matrix ◽  
Fetal Bovine ◽  
Randomised Controlled ◽  
Acellular Dermal

Aim: The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). Method: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks. Results: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9% p=0.008; mPP: 59.5% versus 35.6% p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. Conclusions: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.

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