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

NCT04078555 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

DRUG

ENERGI-F703 GEL

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.

DRUG

ENERGI-F703 GEL matched vehicle

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.

Sponsors & Collaborators

  • Energenesis Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2025-03-15
Completion
2025-06-15
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04078555 on ClinicalTrials.gov