{"title":"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。","authors":"Shayan Farzanbakhsh, Mohammad Reza Amini, Hoda Madani, Bahareh Sadri, Seyedeh Nafiseh Hassani, Nasrin Fallah, Azam Samadian, Raheleh Aghdami, Zahra Khalajasadi, Hossein Baharvand, Massoud Vosough, Ensiyeh Hajizadeh-Saffar","doi":"10.1111/dom.15843","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To assess the safety and efficacy of a local skin substitute product in the treatment of chronic diabetic foot ulcers (DFUs).</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":null,"pages":null},"PeriodicalIF":5.4000,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety evaluation of bi-layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers-SAFESKIN-DFU: A Phase 1 clinical trial.\",\"authors\":\"Shayan Farzanbakhsh, Mohammad Reza Amini, Hoda Madani, Bahareh Sadri, Seyedeh Nafiseh Hassani, Nasrin Fallah, Azam Samadian, Raheleh Aghdami, Zahra Khalajasadi, Hossein Baharvand, Massoud Vosough, Ensiyeh Hajizadeh-Saffar\",\"doi\":\"10.1111/dom.15843\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>To assess the safety and efficacy of a local skin substitute product in the treatment of chronic diabetic foot ulcers (DFUs).</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":158,\"journal\":{\"name\":\"Diabetes, Obesity & Metabolism\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.4000,\"publicationDate\":\"2024-08-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes, Obesity & Metabolism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/dom.15843\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes, Obesity & Metabolism","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/dom.15843","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Safety evaluation of bi-layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers-SAFESKIN-DFU: A Phase 1 clinical trial.
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.
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.