Clinical Trials List
2017-01-01 - 2020-06-30
Phase II
Terminated7
ICD-10E11.621
Type 2 diabetes mellitus with foot ulcer
A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects with Diabetic Foot Ulcers
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
Energenesis Biomedical Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ching-Sung Tasi Division of Plastic Surgery
- YI-CHUN WU Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃傑慧 Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪士淵 Division of Endocrinology
- Jui-Yung Yang Division of Plastic Surgery
- Jiun Ting Yeh Division of Plastic Surgery
- 楊士毅 Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The ulcer closure rate
(Defined as the proportion of subjects with complete ulcer closure at the end of treatment period)
Complete ulcer closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Subjects with complete ulcer closure at Week 12 visit and confirmed at Week 14 visit will be considered as success.
2. Secondary endpoints:
Efficacy:
(1) The accumulated confirmed ulcer closure rate at each of the post-treatment visit
(2) The ulcer closure time
Defined as the time to complete ulcer closure
(3) Percentage change in ulcer size for each post-treatment visit
Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline)
Safety:
(1) Adverse event incidence
(2) Change in physical examination results
(3) Net change from baseline in laboratory test results (include hemoglobin, hematocrit, RBC, platelet, WBC with differential counts, HbA1c, fasting glucose, AST, ALT, creatinine and BUN)
(4) Net change from baseline in vital signs
Inclution Criteria
A subject is eligible for the study if all of the following apply:
(1) With either gender aged at least 20 years old.
(2) With diabetic mellitus (DM; currently under DM medication treatment or naïve DM subject with duplicated HbA1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least one week apart before Screening).
(3) With at least one cutaneous ulcer on the foot (including ulcers on the lower legs) and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If two or more ulcers have the largest size, the one with worst grade will be selected. If two or more ulcers have the largest size and grade, the one with longest duration will be selected.
(4) The target ulcer is classified as grade 1 to 3 ulcer according to Wagner Grading System and with ulcer size of 1 cm2 to 50 cm2 (Grade 3 ulcer subject may enter
the study only if after debridement, the abscess of target ulcer is under control at investigator’s discretion and osteomyelitis does not present).
(5) Subject should be free of any necrosis or infection in soft and bone tissue.
(6) Subject has signed the written informed consent form.
Exclusion Criteria
Any subject meeting any of the exclusion criteria will be excluded from study participation.
(1) With active osteomyelitis.
(2) With target ulcer size decreased by at least 30% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit.
(3) With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), a leukocyte counts < 2,000/mm3, abnormal liver function (AST, ALT>3 x upper limit of normal range).
Note: HbA1c = hemoglobin A1c; AST = aspartate aminotransferase; ALT = alanine aminotransferase
(4) Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents.
(5) With known or suspected hypersensitivity to any ingredients of study product and vehicle.
(6) With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study.
(7) Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period.
(8) Enrollment in any investigational drug trial within 4 weeks before entering this study.
(9) With any condition judged by the investigator that entering the trial may be detrimental to the subject.
The Estimated Number of Participants
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Taiwan
132 participants
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Global
0 participants
