Saher Hamed, Yehuda Ullmann, Mark Belokopytov, Aziz Shoufani, Hoda Kabha, Suher Masri, Zeev Feldbrin, Leonid Kogan, Danny Kruchevsky, Roger Najjar, Paul Y Liu, Jean-Charles Kerihuel, Sadanori Akita, Luc Teot
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引用次数: 2
摘要
糖尿病足溃疡(DFU)是糖尿病的主要致残并发症。越来越多的证据表明,局部促红细胞生成素(EPO)可以促进伤口愈合。本研究的目的是临床评估一种专有的外用含epo的水凝胶治疗DFUs的疗效。我们对20例DFUs患者进行了一项随机对照试验。在14天的筛选期后,20名符合纳入标准的受试者的dfu被随机分配(1:1)到12周的每日局部EPO和标准护理(SOC)治疗或单独SOC治疗。每周评估dfu,直到第12周。主要结局是75%的溃疡愈合或更高。经过12周的治疗,10例DFUs患者中有6例接受局部EPO治疗,8例DFUs患者中有1例单独使用SOC治疗,75%的溃疡愈合。外用EPO和SOC治疗的dfu平均面积明显小于单独使用SOC治疗的dfu(1.2±1.4 cm2 vs 4.2±3.4 cm2;p = 0.023)。局部epo处理的dfu的再上皮化速度比soc处理的dfu快。没有与治疗相关的不良事件。我们得出结论,局部促生成素是促进dfu愈合的一种有希望的治疗方法。临床试验注册号:NCT02361931。
Topical Erythropoietin Accelerates Wound Closure in Patients with Diabetic Foot Ulcers: A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial.
The diabetic foot ulcer (DFU) is a major disabling complication of diabetes mellitus. Growing evidence suggests that topical erythropoietin (EPO) can promote wound healing. The aim of this study is to clinically assess the efficacy of a proprietary topical EPO-containing hydrogel for treating DFUs. We conducted a randomized, controlled trial in 20 patients with DFUs. After a 14-day screening period, the DFUs of 20 eligible participants who fulfilled the inclusion criteria were randomly assigned (1:1) to either a 12-week of daily treatment with topical EPO and standard-of-care (SOC) or SOC treatment alone. The DFUs were assessed weekly until week 12. The primary outcome was 75% ulcer closure or higher. After 12 weeks of treatment, 75% ulcer closure was achieved in 6 of the 10 patients whose DFUs were treated with topical EPO and in one of the 8 patients whose DFUs were treated with SOC alone. The mean area of the DFUs that were treated with topical EPO and SOC was significantly smaller than those treated with SOC alone (1.2 ± 1.4 cm2 vs. 4.2 ± 3.4 cm2; p = 0.023). Re-epithelialization was faster in the topically EPO-treated DFUs than in the SOC-treated DFUs. There were no treatment-related adverse events. We conclude that topical EPO is a promising treatment for promoting the healing of DFUs. Clinical Trial Registration number: NCT02361931.
期刊介绍:
Rejuvenation Research publishes cutting-edge, peer-reviewed research on rejuvenation therapies in the laboratory and the clinic. The Journal focuses on key explorations and advances that may ultimately contribute to slowing or reversing the aging process, and covers topics such as cardiovascular aging, DNA damage and repair, cloning, and cell immortalization and senescence.
Rejuvenation Research coverage includes:
Cell immortalization and senescence
Pluripotent stem cells
DNA damage/repair
Gene targeting, gene therapy, and genomics
Growth factors and nutrient supply/sensing
Immunosenescence
Comparative biology of aging
Tissue engineering
Late-life pathologies (cardiovascular, neurodegenerative and others)
Public policy and social context.