Diabetic FootPhase 2NCT02672436
ENERGI-F703 for Diabetic Foot Ulcers Phase II Study
A Phase 2 study testing ENERGI-F703 in people with Diabetic Foot and Foot Ulcer, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus
- What is being tested?
- ENERGI-F703
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2017to 26 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With either gender aged at least 20 years old
- With diagnosed diabetic mellitus (DM), e.g. currently under DM medication treatment or naïve DM subject with duplicated HbA1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least one week apart before Screening)
- With at least one cutaneous ulcer on the foot (including ulcers on the lower legs) and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If two or more ulcers have the largest size, the one with worst grade will be selected. If two or more ulcers have the largest size and grade, the one with longest duration will be selected.
- The target ulcer is classified as grade 1 to 3 ulcer according to Wagner Grading System and with ulcer size of 1 cm2 to 36 cm2 (Grade 3 ulcer subject may enter the study only if after debridement, the abscess of target ulcer is under control at investigator's discretion and osteomyelitis does not present)
- Diabetic foot ulcers should be free of any necrosis or infection in any soft tissue and bone tissue;
- Subject has signed the written informed consent form
Who cannot join
- With active osteomyelitis
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy either before Screening visit or after completing Initial Phase
- With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), a leukocyte counts < 2,000/mm3, abnormal liver function (AST, ALT>3 x upper limit of normal range) within 14 days before Screening visit or 28 days before Randomization visit Note: HbA1c: hemoglobin A1c; AST: aspartate aminotransferase; ALT: alanine aminotransferase
- Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
- With known or suspected hypersensitivity to any ingredients of study product and vehicle
- With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study
Show all 12Show fewer
- Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period Note: Women with childbearing potential should agree to use a highly effective method of birth control, defined as those, alone or in combination, that result in a low failure rate when used consistently and correctly.
- With the following conditions:
- ankle brachial index (ABI) < 0.4 OR
- ABI between 0.4 and 0.6 (inclusive) and not received appropriate treatment for improving venous and arterial insufficiency Note: Subjects with ABI between 0.4 and 0.6 (inclusive) and having received appropriate surgical or endovenous/endovascular therapy for improving venous and arterial insufficiency considered by investigators such as valvuloplasty, angioplasty, or bypass grafting will be eligible to enter the study at investigator's discretion.
- 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.
About this study
Official title: A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 in Subjects With Diabetic Foot Ulcers
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.
- Conditions
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Wounds
- Being tested
- ENERGI-F703, ENERGI-F703 matched vehicle
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound Healing
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGI-F703Drug
Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers.
ENERGI-F703 matched vehicleDrug
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
| Study group | Role | What they receive |
|---|---|---|
| ENERGI-F703 | Experimental | ENERGI-F703, topical application, 2 times daily for 12 weeks Receives: Drug: ENERGI-F703 |
| Placebo | Placebo comparator | ENERGI-F703 matched vehicle, topical application, 2 times daily for 12 weeks Receives: Drug: ENERGI-F703 matched vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ulcer closure rate
Defined as the proportion of subjects with complete ulcer closure at the end of treatment period
Measured: Week 12
Secondary outcomes (4)
The accumulated confirmed ulcer closure rate at each of the post-treatment visit
Measured: Week 1, 2, 4 ,6 ,8, 10, 12
The ulcer closure time
Defined as the time to complete ulcer closure
Measured: Week 1, 2, 4, 6, 8, 10, 12
Percentage change in ulcer size for each post-treatment visit
Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline)
Measured: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Adverse event incidence
Measured: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start15 Mar 2017
- Primary completion3 Oct 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672436
- Sponsor's protocol ID
- ENERGI-F703-01
- Status last verified
- Nov 2020
- First submitted
- 27 Jan 2016
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang JY, Chen CC, Chang SC, Yeh JT, Huang HF, Lin HC, Lin SH, Lin YH, Wei LG, Liu TJ, Hung SY, Yang HM, Chang HH, Wang CH, Tzeng YS, Huang CH, Chou CY, Lin YS, Yang SY, Chen HM, Lin JT, Cheng YF, Young GH, Huang CF, Kuo YC, Dai NT. ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial. EClinicalMedicine. 2022 Jul 10;51:101497. doi: 10.1016/j.eclinm.2022.101497. eCollection 2022 Sep.
PubMed 35844773
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 in Subjects With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02672436
- Acronym / sponsor ID
- ENERGI-F703-01
- Conditions
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Wounds
- Keywords
- Diabetic Foot Ulcer, Diabetes Mellitus, Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 3 Feb 2016 (estimated)
- 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.
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENERGI-F703 | Experimental | Drug: ENERGI-F703ENERGI-F703, topical application, 2 times daily for 12 weeks |
| Placebo | Placebo comparator | Drug: ENERGI-F703 matched vehicleENERGI-F703 matched vehicle, topical application, 2 times daily for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With either gender aged at least 20 years old
- With diagnosed diabetic mellitus (DM), e.g. currently under DM medication treatment or naïve DM subject with duplicated HbA1c over 6.5% and fasting plasma glucose over 126 mg/dL measured at least one week apart before Screening)
- With at least one cutaneous ulcer on the foot (including ulcers on the lower legs) and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If two or more ulcers have the largest size, the one with worst grade will be selected. If two or more ulcers have the largest size and grade, the one with longest duration will be selected.
- The target ulcer is classified as grade 1 to 3 ulcer according to Wagner Grading System and with ulcer size of 1 cm2 to 36 cm2 (Grade 3 ulcer subject may enter the study only if after debridement, the abscess of target ulcer is under control at investigator's discretion and osteomyelitis does not present)
- Diabetic foot ulcers should be free of any necrosis or infection in any soft tissue and bone tissue;
Key exclusion criteria (12 listed)
- With active osteomyelitis
- With target ulcer size decreased by at least 30% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy either before Screening visit or after completing Initial Phase
- With poor nutritional status (albumin < 2g/dl), poor diabetic control (HbA1c > 12%), a leukocyte counts < 2,000/mm3, abnormal liver function (AST, ALT>3 x upper limit of normal range) within 14 days before Screening visit or 28 days before Randomization visit Note: HbA1c: hemoglobin A1c; AST: aspartate aminotransferase; ALT: alanine aminotransferase
- Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
- With known or suspected hypersensitivity to any ingredients of study product and 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-F703Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers. | Drug | ENERGI-F703 |
| ENERGI-F703 matched vehicleStandard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers. | Drug | Placebo |
Primary outcome
The ulcer closure rate
Time frame: Week 12
Defined as the proportion of subjects with complete ulcer closure at the end of treatment period
4 secondary outcomes
The accumulated confirmed ulcer closure rate at each of the post-treatment visit
Time frame: Week 1, 2, 4 ,6 ,8, 10, 12
The ulcer closure time
Time frame: Week 1, 2, 4, 6, 8, 10, 12
Percentage change in ulcer size for each post-treatment visit
Time frame: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Adverse event incidence
Time frame: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 35844773Yang JY, Chen CC, Chang SC, Yeh JT, Huang HF, Lin HC, Lin SH, Lin YH, Wei LG, Liu TJ, Hung SY, Yang HM, Chang HH, Wang CH, Tzeng YS, Huang CH, Chou CY, Lin YS, Yang SY, Chen HM, Lin JT, Cheng YF, Young GH, Huang CF, Kuo YC, Dai NT. ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial. EClinicalMedicine. 2022 Jul 10;51:101497. doi: 10.1016/j.eclinm.2022.101497. eCollection 2022 Sep.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Diabetic Foot and Foot 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 24 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ulcer closure rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672436, which also lists 1 linked publication.
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 24 Nov 2020.