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ENERGI-F703 GEL for Diabetic Foot Ulcers
Phase 3
Recruiting
Research Sponsored by Energenesis Biomedical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diabetic foot ulcers should be free of any necrosis or infection
Subject must have at least 1 cutaneous ulcer on the foot that has not healed for at least 4 weeks, meeting specific criteria for size and classification according to Wagner Grading System
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
Awards & highlights
Study Summary
This trial is testing a gel for treating diabetic foot ulcers, using a double-blind, randomized study to compare it to vehicle control. Results will be observed for 31 weeks.
Who is the study for?
This trial is for adults with diabetes who have a foot ulcer that hasn't healed in at least 4 weeks, fitting certain size and severity criteria. They must not be pregnant or breastfeeding, use reliable birth control, and have stable blood sugar levels. People can't join if they've had recent treatments that could affect results, their wound is too wet or infected, they have poor circulation in the legs, or other health issues that make it unsafe.Check my eligibility
What is being tested?
The study tests ENERGI-F703 GEL against a placebo gel to see which one is better at healing diabetic foot ulcers. Participants are randomly assigned to one of the two gels without knowing which one they get. The study lasts up to 31 weeks including screening, treatment phase (16 weeks), and safety follow-up (12 weeks).See study design
What are the potential side effects?
While specific side effects aren't listed here, typical concerns may include skin irritation at the application site or allergic reactions to ingredients in the gel. Close monitoring will identify any potential side effects during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diabetic foot ulcer does not have dead tissue or infection.
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I have a foot ulcer that hasn't healed in over 4 weeks.
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I am a man who is either surgically sterile, using reliable birth control, or abstaining from sex during and for 30 days after the study.
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I am 18 years old or older.
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I have diabetes with specific blood sugar and A1c levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, and 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The ulcer complete closure rate
Secondary outcome measures
The frequency and severity of adverse events
The proportion of subjects with complete ulcer closure
The time to ulcer closure
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ENERGI-F703 GELExperimental Treatment1 Intervention
ENERGI-F703, topical application, 2 times daily for 16 weeks
Group II: ENERGI-F703 matched vehiclePlacebo Group1 Intervention
ENERGI-F703 matched vehicle, topical application, 2 times daily for 16 weeks
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Who is running the clinical trial?
Energenesis Biomedical Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
288 Total Patients Enrolled
1 Trials studying Foot Ulcer
141 Patients Enrolled for Foot Ulcer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the past 2 years, except for certain types.Your ankle brachial index is lower than 0.8 or higher than 1.4.My diabetic foot ulcer does not have dead tissue or infection.My ulcer size has reduced by 30% after 2 weeks of standard treatment.My nutrition, blood sugar, white blood cell count, liver function are within normal ranges and I am careful with my medication use.You have a history of HIV, active Hepatitis B, or active Hepatitis C.I have a foot ulcer that hasn't healed in over 4 weeks.My wound leaks a lot but doesn't need dressing changes more than 3 times a day.I am not pregnant, breastfeeding, and I am using effective birth control.I am a man who is either surgically sterile, using reliable birth control, or abstaining from sex during and for 30 days after the study.I have been diagnosed with a bone infection.I am 18 years old or older.I have diabetes with specific blood sugar and A1c levels.
Research Study Groups:
This trial has the following groups:- Group 1: ENERGI-F703 GEL
- Group 2: ENERGI-F703 matched vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted its sanction for ENERGI-F703 GEL?
"Our team at Power has concluded that ENERGI-F703 GEL is relatively safe with a score of 3, owing to the fact that this medication has been through multiple rounds of clinical trials demonstrating its efficacy and safety."
Answered by AI
Has the enrollment period for this experiment opened yet?
"Affirmative. Clinicaltrials.gov indicates that this trial, which was first uploaded on May 30th 2023, is actively seeking individuals for participation. A total of 230 people from one site are needed to complete the study."
Answered by AI
How many human subjects are taking part in this experiment?
"Affirmative, the information posted on clinicaltrials.gov attests that this medical trial is actively recruiting as of June 25th 2023. The initial post was made May 30th 2023 and it requires 230 patients to be enrolled from a single research center."
Answered by AI
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