Clinical trial NCT04078555: A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer
Official title: A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Venous Leg Ulcer
Lead sponsor: Energenesis Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.


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

Primary outcomes:
measure: Incidence of complete ulcer closure
timeFrame: Day -21 to Day 99
Secondary outcomes:
measure: Percentage change in target ulcer area from baseline to each post-treatment visit
timeFrame: Day -21 to Day 85
measure: Time-to-Complete ulcer closure of target ulcer
timeFrame: Day -21 to Day 99
measure: The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit
timeFrame: Day -21 to Day 85
measure: Incidence of vital signs abnormalities
timeFrame: Day -21 to Day 169
measure: Incidence of physical examination abnormalities
timeFrame: Day -21 to Day 169
measure: Incidence of laboratory examination results abnormalities
timeFrame: Day -21 to Day 169
measure: Incidence of AEs and SAEs
timeFrame: Day -21 to Day 169
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References: