Venous Leg UlcerPhase 2NCT04078555
A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer
A Phase 2 study testing ENERGI-F703 GEL in people with Venous Leg Ulcer, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- ENERGI-F703 GEL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2022to 15 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- (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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Cha-Chun Chen, MD
Cha-Chun Chen, MD
About this study
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)
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
- Being tested
- ENERGI-F703 GEL, ENERGI-F703 GEL matched vehicle
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGI-F703 GELDrug
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.
ENERGI-F703 GEL matched vehicleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ENERGI-F703 GEL | Experimental | topical application on target venous leg ulcer, twice daily Receives: Drug: ENERGI-F703 GEL |
| ENERGI-F703 GEL matched vehicle | Placebo comparator | topical application on target venous leg ulcer, twice daily Receives: Drug: ENERGI-F703 GEL matched vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day -21 to Day 99
Secondary outcomes (7)
Percentage change in target ulcer area from baseline to each post-treatment visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day -21 to Day 169
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).
Measured: Day -21 to Day 169
Incidence of AEs and SAEs
Measured: Day -21 to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start26 Jul 2022
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078555
- Sponsor's protocol ID
- ENERGI-F703-02
- Status last verified
- Feb 2024
- First submitted
- 28 Aug 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04078555
- Acronym / sponsor ID
- ENERGI-F703-02
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENERGI-F703 GEL | Experimental | Drug: ENERGI-F703 GELtopical application on target venous leg ulcer, twice daily |
| ENERGI-F703 GEL matched vehicle | Placebo comparator | Drug: ENERGI-F703 GEL matched vehicletopical application on target venous leg ulcer, twice daily |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENERGI-F703 GELThe 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 |
| ENERGI-F703 GEL matched vehicleThe 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 |
Primary outcome
Incidence of complete ulcer closure
Time frame: Day -21 to Day 99
Complete wound closure is defined as 100% skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visit 2 weeks apart.
7 secondary outcomes
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
Time frame: Day -21 to Day 99
The accumulated confirmed target ulcer closure incidence at each of the post-treatment visit
Time frame: Day -21 to Day 85
Incidence of vital signs abnormalities
Time frame: Day -21 to Day 169
Incidence of physical examination abnormalities
Time frame: Day -21 to Day 169
Incidence of laboratory examination results abnormalities
Time frame: Day -21 to Day 169
Incidence of AEs and SAEs
Time frame: Day -21 to Day 169
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENERGI-F703 GEL in people with Venous Leg Ulcer, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifang Cheng, PhD (+886-2-2627-0835 ext. 701, yf@energenesis-biomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete ulcer closure (time frame: Day -21 to Day 99). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.