Safety evaluation of bi-layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers—SAFESKIN-DFU: A Phase 1 clinical trial

IF 5.7 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2024-08-19 DOI:10.1111/dom.15843

Shayan Farzanbakhsh MD, Mohammad Reza Amini PhD, Hoda Madani MD, Bahareh Sadri MSc, Seyedeh Nafiseh Hassani PhD, Nasrin Fallah MSc, Azam Samadian MSc, Raheleh Aghdami MSc, Zahra Khalajasadi MSc, Hossein Baharvand PhD, Massoud Vosough PhD, Ensiyeh Hajizadeh-Saffar PhD

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Abstract

Aim

To assess the safety and efficacy of a local skin substitute product in the treatment of chronic diabetic foot ulcers (DFUs).

Materials and Methods

Five patients were evaluated over 6 months. Skin substitutes were applied twice at 2-week intervals. Patients were monitored for any possible adverse effects and wound improvement.

Results

The results indicated the overall safety of the skin substitute, with only few adverse effects unrelated to this product. Significant reduction in wound size was observed in four patients during the initial 12-week treatment phase, with complete closure in two patients at 24 weeks.

Conclusions

The application of a bi-layered allogeneic keratinocyte and fibroblast skin substitute in patients with chronic DFU was safe and associated with favourable wound healing results. Adherence to standard treatment protocols, including optimal offloading, is essential to maximize the likelihood of successful wound healing.

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治疗糖尿病足溃疡的双层异基因角质细胞和成纤维细胞皮肤替代物的安全性评估--SAFESKIN-DFU：一期临床试验。

目的：评估局部皮肤替代产品治疗慢性糖尿病足溃疡（DFU）的安全性和有效性：对五名患者进行了为期 6 个月的评估。皮肤替代品使用两次，每次间隔两周。对患者可能出现的不良反应和伤口改善情况进行了监测：结果：结果表明皮肤替代品总体安全，只有少数不良反应与该产品无关。在最初的 12 周治疗阶段，4 名患者的伤口明显缩小，其中 2 名患者的伤口在 24 周时完全闭合：结论：在慢性 DFU 患者中应用双层异体角质细胞和成纤维细胞皮肤替代物是安全的，并能带来良好的伤口愈合效果。坚持标准治疗方案，包括最佳卸载，对于最大限度地提高伤口成功愈合的可能性至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.