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| Name | Class |
|---|---|
| A2 Healthcare Taiwan Corporation | INDUSTRY |
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The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENERGI-F703 | Experimental | ENERGI-F703, topical application, 2 times daily for 12 weeks |
|
| Placebo | Placebo Comparator | ENERGI-F703 matched vehicle, topical application, 2 times daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENERGI-F703 | Drug | Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ulcer closure rate | Defined as the proportion of subjects with complete ulcer closure at the end of treatment period | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Defined as the time to complete ulcer closure | Week 1, 2, 4, 6, 8, 10, 12 |
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Inclusion Criteria:
Exclusion Criteria:
With active osteomyelitis
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
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
Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
With known or suspected hypersensitivity to any ingredients of study product and vehicle
With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study
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.
With the following conditions:
Enrollment in any investigational drug trial within 4 weeks before entering this study
With any condition judged by the investigator that entering the trial may be detrimental to the subject
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35844773 | Derived | 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. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D016523 | Foot Ulcer |
| D003920 | Diabetes Mellitus |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ENERGI-F703 matched vehicle | Drug | Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers. |
|
| 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) | Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24 |
| Adverse event incidence | Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24 |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |