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New treatment option for Diabetic Foot Ulcer
Official title A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
ClinicalTrials.gov ID: NCT05930210
What this study is testing
What is ENERGI-F703 GEL?
ENERGI-F703 GEL is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for diabetic foot ulcer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be at least 18 years old.
- Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or people with naïve DM with duplicated...
- 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...
- 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
You likely can't join if
- History or evidence of osteomyelitis as confirmed by the investigator. An x-ray/pathology assessment of debridement or a probe-to-bone (PTB) test...
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
- people with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be...
- With poor nutritional status (serum albumin \ 12%), a leukocyte counts \ 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
See the full eligibility criteria
- Subject must be at least 18 years old.
- Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or people with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at...
- 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...
- 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
- Male people 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...
- Female people 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...
- 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.
- 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...
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization
- people 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 \ 12%), a leukocyte counts \ 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
- 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...
- 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...
- 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 \ 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 -
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Palmetto Bay, Florida, United States
- Columbus, Georgia, United States
- Jackson, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Salem, Virginia, United States
- Chiayi City, Taiwan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Palmetto Bay, Florida, United States; Columbus, Georgia, United States; Jackson, Tennessee, United States; Houston, Texas, United States; Salt Lake City, Utah, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.