Clinical trial NCT02672436: ENERGI-F703 for Diabetic Foot Ulcers Phase II Study
Official title: A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 in Subjects With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Wounds
Keywords: Diabetic Foot Ulcer
Diabetes Mellitus
Wound Healing
Lead sponsor: Energenesis Biomedical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: A2 Healthcare Taiwan Corporation
First posted: 2016-02-03
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. With either gender aged at least 20 years old
2. With diagnosed diabetic mellitus (DM), e.g. 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 36 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. Diabetic foot ulcers should be free of any necrosis or infection in any soft tissue and bone tissue;
6. Subject has signed the written informed consent form

Exclusion Criteria:

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 either before Screening visit or after completing Initial Phase
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) within 14 days before Screening visit or 28 days before Randomization visit 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 Note: Women with childbearing potential should agree to use a highly effective method of birth control, defined as those, alone or in combination, that result in a low failure rate when used consistently and correctly.
8. With the following conditions:

   1. ankle brachial index (ABI) \< 0.4 OR
   2. ABI between 0.4 and 0.6 (inclusive) and not received appropriate treatment for improving venous and arterial insufficiency Note: Subjects with ABI between 0.4 and 0.6 (inclusive) and having received appropriate surgical or endovenous/endovascular therapy for improving venous and arterial insufficiency considered by investigators such as valvuloplasty, angioplasty, or bypass grafting will be eligible to enter the study at investigator's discretion.
9. Enrollment in any investigational drug trial within 4 weeks before entering this study
10. With any condition judged by the investigator that entering the trial may be detrimental to the subject

Primary outcomes:
measure: The ulcer closure rate
timeFrame: Week 12
Secondary outcomes:
measure: The accumulated confirmed ulcer closure rate at each of the post-treatment visit
timeFrame: Week 1, 2, 4 ,6 ,8, 10, 12
measure: The ulcer closure time
timeFrame: Week 1, 2, 4, 6, 8, 10, 12
measure: Percentage change in ulcer size for each post-treatment visit
timeFrame: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
measure: Adverse event incidence
timeFrame: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
citation: Yang JY, Chen CC, Chang SC, Yeh JT, Huang HF, Lin HC, Lin SH, Lin YH, Wei LG, Liu TJ, Hung SY, Yang HM, Chang HH, Wang CH, Tzeng YS, Huang CH, Chou CY, Lin YS, Yang SY, Chen HM, Lin JT, Cheng YF, Young GH, Huang CF, Kuo YC, Dai NT. ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial. EClinicalMedicine. 2022 Jul 10;51:101497. doi: 10.1016/j.eclinm.2022.101497. eCollection 2022 Sep.