Diabetic Foot UlcerPhase 3NCT05930210
A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
A Phase 3 study testing ENERGI-F703 GEL in people with Diabetic Foot Ulcer and Foot Ulcer, run by Energenesis Biomedical Co., Ltd. at 24 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus
- What is being tested?
- ENERGI-F703 GEL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 30 May 2023to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years old.
- 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.
- 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.
- 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.
- Diabetic foot ulcers should be free of any necrosis or infection
- Subject has signed the written informed consent form
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- Male subjects must be surgically sterile 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.
- 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.
Who cannot join
- 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. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
- 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
- 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
- Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
- With known or suspected hypersensitivity to any ingredients of study product and vehicle
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- With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study (patients who have undergone peripheral angioplasty should be excluded unless the surgery was performed at least 30 days prior to screening)
- 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 (within 6 months prior to screening includes both drug abuse and alcohol abuse)
- History or positive test results for HIV
- 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
- Ankle brachial index <0.8 or >1.4
- 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 -
Trial locations and contacts
24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 2 countries
Taiwan14 sites, 14 recruiting
- Recruiting
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City
Chien-Liang Fang, Dr.
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Shu-Hung Huang, Dr.
- Recruiting
China Medical University Hospital
Taichung
Hsin-Han Chen, Dr.
- Recruiting
Kung Tien General Hospital
Taichung
Shih-Ting Tseng, Dr.
- Recruiting
Taichung Veterans General Hospital
Taichung
Yiling Lin, Dr.
- Recruiting
Chi Mei Medical Center
Tainan
Chun Chia Chen, Dr.
- Recruiting
National Cheng Kung University Hospital
Tainan
Shin-Chen Pan, Dr.
- Recruiting
Cathay General Hospital
Taipei
Chi-Ming Pu, Dr.
- Recruiting
MacKay Memorial Hospital
Taipei
Ming Feng Tsai, Dr.
- Recruiting
National Taiwan University Hospital
Taipei
Hui-Fu Huang, Dr.
- Recruiting
Shin Kong Wu Ho Su Memorial Hospital
Taipei
Cha-Chun Chen, Dr.
- Recruiting
Taipei Veterans General Hospital
Taipei
Chih-Hsun Lin, Dr.
- Recruiting
Tri-Service General Hospital
Taipei
Hao-Yu Chiao, Dr.
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
Jiun-Ting Yeh, Dr.
United States10 sites, 10 recruiting
- Recruiting
IACT Health
Columbus, Georgia, 31904
Joseph Surber, Dr.
- Recruiting
Mt. Olympus Medical Research
Houston, Texas, 77095
Julie Lester, Dr.
- Recruiting
The Jackson Clinic PA
Jackson, Tennessee, 38305
Kellie Wallace-Wilding, Dr.
- Recruiting
A and D Doctor Center
Miami, Florida, 33135
Yordan Orive, Dr.
- Recruiting
Bioclinical Research
Miami, Florida, 33155
Rogelio Iglesias, Dr.
- Recruiting
Reliant Medical Research
Miami, Florida, 33165
Ramses Vega, Dr.
- Recruiting
Advanced Medical Research Institute
Miami, Florida, 33174-3201
Enrique Pelayo, Dr.
- Recruiting
New Horizons Research
Palmetto Bay, Florida, 33176
Derrick H. Diaz, Dr.
- Recruiting
Salem Veterans Affairs Medical Center VAMC
Salem, Virginia, 24153-6404
Aliza Lee, Dr.
- Recruiting
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Clark Larsen, Dr.
About this study
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
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.
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound
- Being tested
- ENERGI-F703 GEL, ENERGI-F703 matched vehicle
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound Healing
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGI-F703 GELDrug
Standard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicleDrug
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
| Study group | Role | What they receive |
|---|---|---|
| ENERGI-F703 GEL | Experimental | ENERGI-F703, topical application, 2 times daily for 16 weeks Receives: Drug: ENERGI-F703 GEL |
| ENERGI-F703 matched vehicle | Placebo comparator | ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks Receives: Drug: ENERGI-F703 matched vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 16
Secondary outcomes (3)
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
Measured: Weeks 4, 6, 8, 10, 12, 14, and 16
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
Measured: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
The proportion of subjects with complete ulcer closure
Proportion of subjects with confirmed complete ulcer closure as assessed by the investigator.
Measured: Weeks 4, 6, 8, 10, 12, 14, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start30 May 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930210
- Sponsor's protocol ID
- ENERGI-F703-04
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05930210
- Acronym / sponsor ID
- ENERGI-F703-04
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer, Diabetes Mellitus, Wound
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound Healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENERGI-F703 GEL | Experimental | Drug: ENERGI-F703 GELENERGI-F703, topical application, 2 times daily for 16 weeks |
| ENERGI-F703 matched vehicle | Placebo comparator | Drug: ENERGI-F703 matched vehicleENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject must be at least 18 years old.
- 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.
- 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.
- 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.
- Diabetic foot ulcers should be free of any necrosis or infection
Key exclusion criteria (13 listed)
- 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. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
- 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
- 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
- Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENERGI-F703 GELStandard of care and ENERGI-F703 GEL are applied for the treatment of diabetic foot ulcers. | Drug | ENERGI-F703 GEL |
| ENERGI-F703 matched vehicleStandard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers. | Drug | ENERGI-F703 matched vehicle |
Primary outcome
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.
3 secondary outcomes
The time to ulcer closure
Time frame: Weeks 4, 6, 8, 10, 12, 14, and 16
The frequency and severity of adverse events
Time frame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
The proportion of subjects with complete ulcer closure
Time frame: Weeks 4, 6, 8, 10, 12, 14, and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENERGI-F703 GEL in people with Diabetic Foot Ulcer and Foot Ulcer, run by Energenesis Biomedical Co., Ltd. at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifang Cheng, PhD (+886-2-26270835, ct@energenesis-biomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ulcer complete closure rate (time frame: Weeks 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.