A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer

• ClinicalTrials.gov Identifier: NCT05930210
• Recruitment Status: Recruiting
• First Posted: July 5, 2023
• Last Update Posted: November 24, 2023
• Sponsor: Energenesis Biomedical Co., Ltd.
• Information provided by (Responsible Party): Energenesis Biomedical Co., Ltd.

Tracking Information

• First Submitted Date: June 15, 2023
• First Posted Date: July 5, 2023
• Last Update Posted Date: November 24, 2023
• Actual Study Start Date: May 30, 2023
• Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 25, 2023)

The ulcer complete closure rate [ Time Frame: Weeks 16 ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 25, 2023)

• The time to ulcer closure [ Time Frame: Weeks 4, 6, 8, 10, 12, 14, and 16 ]
  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
• The frequency and severity of adverse events [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28 ]
  Frequency and severity of adverse events (AEs), including treatment emergent AEs, serious AEs, treatment-related AEs, and treatment-related serious AEs
• The proportion of subjects with complete ulcer closure [ Time Frame: Weeks 4, 6, 8, 10, 12, 14, and 16 ]
  Proportion of subjects with confirmed complete ulcer closure as assessed by the investigator.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
• Official Title: A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase III Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Diabetic Foot Ulcers
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Diabetic Foot Ulcer
• Foot Ulcer
• Diabetes Mellitus
• Wound

Intervention

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

Study Arms

• Experimental: ENERGI-F703 GEL
  ENERGI-F703, topical application, 2 times daily for 16 weeks
  Intervention: Drug: ENERGI-F703 GEL
• Placebo Comparator: ENERGI-F703 matched vehicle
  ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks
  Intervention: Drug: ENERGI-F703 matched vehicle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 25, 2023): 230
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2024
• Estimated Primary Completion Date: July 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Yifang Cheng, PhD; +886-2-26270835 ext 701; yf@energenesis-biomedical.com

• Listed Location Countries: Taiwan, United States

Administrative Information

• NCT Number: NCT05930210
• Other Study ID Numbers: ENERGI-F703-04
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Energenesis Biomedical Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Energenesis Biomedical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Energenesis Biomedical Co., Ltd.
• Verification Date: June 2023