A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer

Launched by ENERGENESIS BIOMEDICAL CO., LTD. · Sep 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ENERGI-F703 GEL for patients with venous leg ulcers, which are wounds on the lower leg that don’t heal properly. The trial is looking for adults aged 20 and older who have at least one venous leg ulcer that has not healed for at least four weeks. To qualify, the ulcer must be a certain size, and participants should be able to tolerate compression therapy, which helps improve blood flow in the legs.

Participants in the study will be randomly assigned to receive either the gel or a placebo (a treatment that does not contain the active ingredient) over a period of 84 days, followed by another 84 days of follow-up to see how well the treatment works. Throughout the trial, participants will be monitored for safety and effectiveness. It’s important to note that certain health conditions or recent treatments may exclude someone from participating, but if you think you might qualify, this could be an opportunity to help test a new option for healing venous leg ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. With either gender aged at least 20 years old
• • 2. With venous reflux \>0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
• • 3. With at least one venous ulcer on the lower leg (knee to ankle inclusive) and not healing for at least 4 weeks. The ulcer with the largest surface area will be selected as target ulcer. If two or more ulcers have the largest size, the one with the longest duration will be selected
• • 4. With the target ulcer size of 2 cm2 to 50 cm2
• • 5. Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
• • 6. Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
• • 7. Able to tolerate compression therapy
• • 8. Subject has signed the written informed consent form
• Exclusion Criteria:
• • 1. Target VLU With active cellulitis or osteomyelitis
• • 2. With target ulcer size decreased by at least 30% after 2 weeks of standard care
• • 3. With poor nutritional status (albumin \< 2g/dl), poor diabetic control (HbA1c \> 12%), a leukocyte counts \< 2,000/mm3, abnormal liver function (AST, ALT\>3 × upper limit of normal range) tests within 14 days prior to Screening visit or 28 days prior to Randomization visit
• • 4. Requiring treatment with chemotherapeutic agents
• • 5. With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
• • 6. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to Screening visit
• 7. (1) Female subject of childbearing potential who:
• • is lactating; or
• • has positive pregnancy test result at eligibility checking; or
• • refuses to adopt at least one form of birth control from signing informed consent to the end of study
• Note:
• Acceptable forms include:
• • Established use of oral, injected or implanted hormonal methods of contraception. Placement of an intrauterine device (IUD) or intrauterine system (IUS).Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps)
• • 7(2) Male subject with female spouse/partners who are of childbearing potential refuses to adopt at least one form of birth control (at least one of which must be a barrier method) from signing informed consent to the end of study)
• • 8. With ankle brachial index (ABI) \< 0.6
• • 9. Enrollment in any investigational drug trial within 4 weeks before entering this study
• • 10. With any condition judged by the investigator that entering the trial may be detrimental to the subject