ENERGI-F703凝胶作为糖尿病足和腿部溃疡的一种新型局部治疗方法：一项多中心、随机、双盲、II期试验。
ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial.
作者信息
Yang Jui-Yung, Chen Cha-Chun, Chang Shun-Cheng, Yeh Jiun-Ting, Huang Hui-Fu, Lin Hwang-Chi, Lin Shang-Hsi, Lin Yu-Hsien, Wei Lin-Gwei, Liu Tom J, Hung Shih-Yuan, Yang Hui-Mei, Chang Hui-Hsiu, Wang Chih-Hsin, Tzeng Yuan-Sheng, Huang Chieh-Huei, Chou Chang-Yi, Lin Ying-Sheng, Yang Shih-Yi, Chen Han-Min, Lin Jiun-Tsai, Cheng Yi-Fang, Young Guang-Huar, Huang Chun-Fang, Kuo Ya-Chun, Dai Niann-Tzyy
机构信息
Division of General Plastic Surgery, Taipei Chang Gung Memorial Hospital, Taipei, Taiwan.
Division of Plastic Surgery, Shin Kong Memorial Wu Ho-Su Hospital, Taipei, Taiwan.
出版信息
EClinicalMedicine. 2022 Jul 10;51:101497. doi: 10.1016/j.eclinm.2022.101497. eCollection 2022 Sep.
BACKGROUND
Diabetic foot and leg ulcers are a major cause of disability among patients with diabetes mellitus. A topical gel called ENERGI-F703, applied twice daily and with adenine as its active pharmaceutical ingredient, accelerated wound healing in diabetic mice. The current study evaluated the safety and efficacy of ENERGI-F703 for patients with diabetic foot and leg ulcers.
METHODS
This randomized, double-blind, multicenter, phase II trial recruited patients from eight medical centers in Taiwan. Patients with intractable diabetic foot and leg ulcers (Wagner Grade 1-3 without active osteomyelitis) were randomly assigned (2:1) to receive topical ENERGI-F703 gel or vehicle gel twice daily for 12 weeks or until complete ulcer closure. The investigator, enrolled patients and site personnel were masked to treatment allocation. Intention to treat (ITT) population and safety population were patient to primary analyses and safety analyses, respectively. Primary outcome was complete ulcer closure rate at the end of treatment. This trial is registered with ClinicalTrials.gov, number NCT02672436.
FINDINGS
Starting from March 15, 2017 to December 26, 2019, 141 patients were enrolled as safety population and randomized into ENERGI-F703 gel (n = 95) group or vehicle gel (n = 46) group. In ITT population, ENERGI-F703 (n = 90) and vehicle group showed ulcer closure rates of 36.7% (95% CI = 26.75% - 47.49%) and 26.2% (95% CI = 13.86% - 42.04%) with difference of 9.74 % (95 % CI = -6.74% - 26.23%) and 25% quartiles of the time to complete ulcer closure of 69 days and 84 days, respectively. There were 25 (26.3%) patients in ENERGI-F703 group and 11 (23.9%) patients in vehicle group experiencing serious adverse events and five deaths occurred during the study period, none of them related to the treatment.
INTERPRETATION
Our study suggests that ENERGI-F703 gel is a safe and well-tolerated treatment for chronic diabetic foot and leg ulcers. Further studies are needed to corroborate our findings in light of limitations.
FUNDING
Energenesis Biomedical Co., Ltd.
背景
糖尿病足和腿部溃疡是糖尿病患者致残的主要原因。一种名为ENERGI-F703的外用凝胶，每日涂抹两次，其活性药物成分为腺嘌呤，可加速糖尿病小鼠的伤口愈合。本研究评估了ENERGI-F703治疗糖尿病足和腿部溃疡患者的安全性和有效性。
方法
这项随机、双盲、多中心的II期试验从台湾的八个医疗中心招募患者。患有顽固性糖尿病足和腿部溃疡（瓦格纳分级1-3级且无活动性骨髓炎）的患者被随机分配（2:1），每天两次接受外用ENERGI-F703凝胶或赋形剂凝胶治疗，为期12周或直至溃疡完全愈合。研究者、入组患者和研究点工作人员均对治疗分配情况不知情。意向性治疗（ITT）人群和安全性人群分别用于主要分析和安全性分析。主要结局是治疗结束时的溃疡完全愈合率。本试验已在ClinicalTrials.gov注册，注册号为NCT02672436。
结果
从2017年3月15日至2019年12月26日，141名患者作为安全性人群入组并随机分为ENERGI-F703凝胶组（n = 95）或赋形剂凝胶组（n = 46）。在ITT人群中，ENERGI-F703组（n = 90）和赋形剂组的溃疡愈合率分别为36.7%（95%CI = 26.75% - 47.49%）和26.2%（95%CI = 13.86% - 42.04%），差异为9.74%（95%CI = -6.74% - 26.23%），溃疡完全愈合时间的第25百分位数分别为69天和84天。ENERGI-F703组有25名（26.3%）患者，赋形剂组有11名（23.9%）患者发生严重不良事件，研究期间有5例死亡，均与治疗无关。
解读
我们的研究表明，ENERGI-F703凝胶是一种治疗慢性糖尿病足和腿部溃疡安全且耐受性良好的疗法。鉴于存在的局限性，需要进一步研究来证实我们的发现。
资助
Energenesis Biomedical Co., Ltd.
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