A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase III Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Diabetic Foot Ulcers

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

开始日期2023-05-30

申办/合作机构

华安医学股份有限公司

NCT04078555 / Recruiting临床2期

A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)

This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.

开始日期2022-07-26

申办/合作机构

华安医学股份有限公司

NCT02672436 / Completed临床2期

A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 in Subjects With Diabetic Foot Ulcers

The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.

开始日期2017-03-15

申办/合作机构

华安医学股份有限公司

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100 项与 ENERGI-F703 相关的临床结果

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100 项与 ENERGI-F703 相关的转化医学

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100 项与 ENERGI-F703 相关的专利（医药）

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项与 ENERGI-F703 相关的文献（医药）

2022-09-01·EClinicalMedicine

ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial

Article

作者: Huang, Chieh-Huei ; Lin, Hwang-Chi ; Lin, Shang-Hsi ; Huang, Hui-Fu ; Liu, Tom J ; Young, Guang-Huar ; Lin, Yu-Hsien ; Yang, Hui-Mei ; Chang, Hui-Hsiu ; Wang, Chih-Hsin ; Lin, Jiun-Tsai ; Kuo, Ya-Chun ; Lin, Ying-Sheng ; Chang, Shun-Cheng ; Huang, Chun-Fang ; Yeh, Jiun-Ting ; Yang, Jui-Yung ; Hung, Shih-Yuan ; Chou, Chang-Yi ; Tzeng, Yuan-Sheng ; Chen, Cha-Chun ; Wei, Lin-Gwei ; Cheng, Yi-Fang ; Yang, Shih-Yi ; Chen, Han-Min ; Dai, Niann-Tzyy

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^th, 2017 to December 26^th, 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.

100 项与 ENERGI-F703 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病足溃疡	临床3期	美国	华安医学股份有限公司	2023-05-30
糖尿病足溃疡	临床3期	中国台湾	华安医学股份有限公司	2023-05-30
创伤和损伤	临床3期	美国	华安医学股份有限公司	2023-05-30
创伤和损伤	临床3期	中国台湾	华安医学股份有限公司	2023-05-30
静脉曲张溃疡	临床2期	中国台湾	华安医学股份有限公司	2022-07-26
褥疮感染	临床前	中国台湾	华安医学股份有限公司	2024-05-20
大疱性表皮松解	临床前	中国台湾	华安医学股份有限公司	2024-05-20

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02672436 (Pubmed) 人工标引	临床2期	糖尿病足 \| 下肢溃疡	141	ENERGI-F703	艱築壓鹽遞淵糧夢壓鬱(獵遞鏇淵衊範構製獵網) = 簾製鬱獵繭簾獵齋餘獵積顧遞廠窪衊壓獵餘製 (積鹽構廠衊膚膚網範憲 )	积极	2022-07-10
				vehicle gel	艱築壓鹽遞淵糧夢壓鬱(獵遞鏇淵衊範構製獵網) = 糧憲觸廠餘醖鏇餘繭顧積顧遞廠窪衊壓獵餘製 (積鹽構廠衊膚膚網範憲 )