Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers

Summary

The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest. SkinTE is applied directly to the wound with the goal of promoting healing. In addition to providing treatment, the program will collect safety and efficacy data. This data will help us understand the potential risks and benefits of SkinTE® when used in a real-world setting. PolarityBio® provides research funding to the study site to support data collection.

Timeline

Start

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Primary completion

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Completion

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Outcome

Met primary endpoint

paper there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). PMID 37402533 ↗

Publications

• Results Armstrong DG, Orgill DP, Galiano R, Glat PM, Didomenico L, Sopko NA, Swanson EW, Sigal F, Snyder R, Li WW, Carter M, Zelen CM. A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis. Int Wound J. 2023 Dec;20(10):4083-4096. doi: 10.1111/iwj.14301. Epub 2023 Jul 4.
• Results Armstrong DG, Orgill DP, Galiano R, Glat PM, Carter M, Zelen CM, Li WW. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020 Oct;17(5):1366-1375. doi: 10.1111/iwj.13404. Epub 2020 May 26.

Drugs

Indications