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

Primary Purpose

Venous Leg Ulcer

Status

Recruiting

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

ENERGI-F703 GEL

ENERGI-F703 GEL matched vehicle

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

With either gender aged at least 20 years old
With venous reflux >0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit
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
With the target ulcer size of 2 cm2 to 50 cm2
Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone
Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue
Able to tolerate compression therapy
Subject has signed the written informed consent form

Exclusion Criteria:

Target VLU With active cellulitis or osteomyelitis
With target ulcer size decreased by at least 30% after 2 weeks of standard care
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
Requiring treatment with chemotherapeutic agents
With known or suspected hypersensitivity to any ingredients of IP and matched vehicle
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
(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)
With ankle brachial index (ABI) < 0.6
Enrollment in any investigational drug trial within 4 weeks before entering this study
With any condition judged by the investigator that entering the trial may be detrimental to the subject

Sites / Locations

Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ENERGI-F703 GEL

ENERGI-F703 GEL matched vehicle

Arm Description

topical application on target venous leg ulcer, twice daily

Outcomes

Primary Outcome Measures

Incidence 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.

Secondary Outcome Measures

Percentage change in target ulcer area from baseline to each post-treatment visit

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.

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.

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.

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.

Incidence of laboratory examination results abnormalities

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).

Incidence of AEs and SAEs

Full Information

NCT ID

NCT04078555

First Posted

August 28, 2019

Last Updated

January 13, 2023

Sponsor

Energenesis Biomedical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04078555

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2022 (Actual)

Primary Completion Date

March 15, 2025 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Energenesis Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ENERGI-F703 GEL

Arm Type

Experimental

Arm Description

topical application on target venous leg ulcer, twice daily

Arm Title

ENERGI-F703 GEL matched vehicle

Arm Type

Placebo Comparator

Arm Description

topical application on target venous leg ulcer, twice daily

Intervention Type

Drug

Intervention Name(s)

ENERGI-F703 GEL

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

ENERGI-F703 GEL matched vehicle

Intervention Description

Primary Outcome Measure Information:

Title

Incidence of complete ulcer closure

Description

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

Secondary Outcome Measure Information:

Title

Percentage change in target ulcer area from baseline to each post-treatment visit

Time Frame

Day -21 to Day 85

Title

Time-to-Complete ulcer closure of target ulcer

Description

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

Title

The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit

Description

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

Title

Incidence of vital signs abnormalities

Description

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

Title

Incidence of physical examination abnormalities

Description

Time Frame

Day -21 to Day 169

Title

Incidence of laboratory examination results abnormalities

Description

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

Title

Incidence of AEs and SAEs

Time Frame

Day -21 to Day 169

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: With either gender aged at least 20 years old With venous reflux >0.1 sec measured by duplex ultrasound imaging dated within 6 months prior to the Screening visit 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 With the target ulcer size of 2 cm2 to 50 cm2 Target VLU involves a full thickness skin loss, but without exposure of tendon, muscle, or bone Target VLU should be free of any necrosis or infection in any soft tissue and bone tissue Able to tolerate compression therapy Subject has signed the written informed consent form Exclusion Criteria: Target VLU With active cellulitis or osteomyelitis With target ulcer size decreased by at least 30% after 2 weeks of standard care 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 Requiring treatment with chemotherapeutic agents With known or suspected hypersensitivity to any ingredients of IP and matched vehicle 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 (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) With ankle brachial index (ABI) < 0.6 Enrollment in any investigational drug trial within 4 weeks before entering this study With any condition judged by the investigator that entering the trial may be detrimental to the subject

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yifang Cheng, PhD

Phone

+886-2-2627-0835

Ext

701

yf@energenesis-biomedical.com

Facility Information:

Facility Name

Shin Kong Wu Ho-Su Memorial Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cha-Chun Chen, MD

First Name & Middle Initial & Last Name & Degree

Cha-Chun Chen, MD

12. IPD Sharing Statement

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

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