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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05930210
Other study ID # ENERGI-F703-04
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 30, 2023
Est. completion date December 1, 2024

Study information

Verified date June 2023
Source Energenesis Biomedical Co., Ltd.
Contact Yifang Cheng, PhD
Phone +886-2-26270835
Email yf@energenesis-biomedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 230
Est. completion date December 1, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject must be at least 18 years old. 2. Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or subjects with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least 1 week apart before screening. 3. Subject must have at least 1 cutaneous ulcer on the foot and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If 2 or more ulcers have the largest size, the one with worst grade will be selected. If 2 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 Grade 2 ulcer according to Wagner Grading System and with ulcer size of 1.5 cm2 to 25 cm2. 5. Diabetic foot ulcers should be free of any necrosis or infection 6. Subject has signed the written informed consent form 7. Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study treatment administration. 8. Female subjects are eligible only if all of the following apply: - Not pregnant with a negative serum pregnancy test at Screening visit and negative urine pregnancy test within 24 hours before randomization (test not required for females of non-childbearing potential, defined as surgically sterile [eg, hysterectomy or bilateral oophorectomy] or postmenopausal [amenorrheic for at least 1 year]) - Not lactating - Not planning to become pregnant during the study - If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study and at least 30 days after study treatment administration. Exclusion Criteria: 1. History or evidence of osteomyelitis as confirmed by the investigator. An x-ray/pathology assessment of debridement or a probe-to-bone (PTB) test will be used to determine presence of osteomyelitis. 2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization 3. Subjects with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be selected as target ulcers 4. With poor nutritional status (serum albumin <2g/dL or prealbumin <10 mg/dL), poor diabetic control (hemoglobin A1c >12%), a leukocyte counts <2,000/mm3, abnormal liver function (aspartate aminotransferase, alanine aminotransferase >3 x upper limit of normal range) within 21 days before Randomization visit 5. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents 6. With known or suspected hypersensitivity to any ingredients of study product and vehicle 7. With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study 8. Known or suspected history of drug abuse or a recent history of alcohol abuse (regularly drinks >4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 6 months prior to screening 9. History or positive test results for HIV, presence of active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV) 1. Hepatitis B surface antigen positive at screening is exclusionary 2. Subjects with history of past or resolved HBV infection or hepatitis B core antibody positive at screening are eligible if HBV DNA viral load =2000 IU/mL in the absence of antiviral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases values 3. Subjects with a history of HCV infection or HCV antibody positive at screening are eligible if HCV viral load is below the level of detection 10. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix 11. Ankle brachial index <0.8 or >1.4 12. Enrollment in any investigational drug trial within 4 weeks before entering this study 13. With any condition judged by the investigator that entering the trial may be detrimental to the subject -

Study Design


Intervention

Drug:
ENERGI-F703 GEL
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicle
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Shin Kong Wu Ho Su Memorial Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan
United States PanAmerican Clinical Research Brownsville Brownsville Texas
United States Alliance Research Institute Canoga Park California
United States IACT Health Columbus Georgia
United States Mt. Olympus Medical Research Houston Texas
United States The Jackson Clinic PA Jackson Tennessee
United States A and D Doctor Center Miami Florida
United States Advanced Medical Research Institute Miami Florida
United States Bioclinical Research Miami Florida
United States Century Research Miami Florida
United States Reliant Medical Research Miami Florida
United States New Horizons Research Palmetto Bay Florida
United States Salem Veterans Affairs Medical Center VAMC Salem Virginia
United States Wasatch Clinical Research Salt Lake City Utah
United States 1Foot 2Foot Suffolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Energenesis Biomedical Co., Ltd.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The ulcer complete closure rate Proportion of subjects with a recording of complete ulcer closure at Week 16 (the end of the treatment period) as assessed by the investigator, where such closure is subsequently confirmed at 2 consecutive study visits over a 2-week period (ie, by Week 18). A complete ulcer closure is defined as 100% skin re epithelialization without drainage or dressing requirements. Weeks 16
Secondary The time to ulcer closure Time to ulcer closure in weeks, defined as the time from randomization to first record of complete closure, as assessed by the investigator, where complete closure is subsequently confirmed at 2 consecutive study visits over a 2-week period Weeks 4, 6, 8, 10, 12, 14, and 16
Secondary The frequency and severity of adverse events Frequency and severity of adverse events (AEs), including treatment emergent AEs, serious AEs, treatment-related AEs, and treatment-related serious AEs Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
Secondary The proportion of subjects with complete ulcer closure Proportion of subjects with confirmed complete ulcer closure as assessed by the investigator. Weeks 4, 6, 8, 10, 12, 14, and 16
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