Diabetes Mellitus, Diabetic Foot, Foot Ulcer, Wounds
Conditions
Keywords
Diabetic Foot Ulcer, Diabetes Mellitus, Wound Healing
Brief summary
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.
Interventions
DRUGENERGI-F703
Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers.
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
Sponsors
A2 Healthcare Taiwan Corporation
Energenesis Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ulcer closure rate | Week 12 | Defined as the proportion of subjects with complete ulcer closure at the end of treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The accumulated confirmed ulcer closure rate at each of the post-treatment visit | Week 1, 2, 4 ,6 ,8, 10, 12 | — |
| The ulcer closure time | Week 1, 2, 4, 6, 8, 10, 12 | Defined as the time to complete ulcer closure |
| Percentage change in ulcer size for each post-treatment visit | Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24 | Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline) |
| Adverse event incidence | Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24 | — |
Countries
Taiwan
Outcome results
None listed