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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.
The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
RECRUITINGIncidence of complete ulcer closure
Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.
Time frame: Day -21 to Day 99
Percentage change in target ulcer area from baseline to each post-treatment visit
Time frame: Day -21 to Day 85
Time-to-Complete ulcer closure of target ulcer
Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.
Time frame: Day -21 to Day 99
The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit
Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.
Time frame: Day -21 to Day 85
Incidence of vital signs abnormalities
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Time frame: Day -21 to Day 169
Incidence of physical examination abnormalities
Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others.
Time frame: Day -21 to Day 169
Incidence of laboratory examination results abnormalities
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The laboratory examinations include Hematology tests (CBC), Biochemistry (AST, ALP, ALT, serum creatinine, BUN, albumin and fasting glucose) and Urinalysis (pH, glucose, RBC, WBC and protein).
Time frame: Day -21 to Day 169
Incidence of AEs and SAEs
Time frame: Day -21 to Day 169