ENERGI-F703 for Diabetic Foot Ulcers Phase II Study

November 23, 2020 updated by: Energenesis Biomedical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. With either gender aged at least 20 years old
  2. 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)
  3. 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.
  4. 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)
  5. Diabetic foot ulcers should be free of any necrosis or infection in any soft tissue and bone tissue;
  6. Subject has signed the written informed consent form

Exclusion Criteria:

  1. With active osteomyelitis
  2. 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
  3. 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
  4. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents
  5. With known or suspected hypersensitivity to any ingredients of study product and vehicle
  6. With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study
  7. 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.

  8. With the following conditions:

    1. ankle brachial index (ABI) < 0.4 OR
    2. 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.
  9. Enrollment in any investigational drug trial within 4 weeks before entering this study
  10. With any condition judged by the investigator that entering the trial may be detrimental to the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ENERGI-F703
ENERGI-F703, topical application, 2 times daily for 12 weeks
Drug: ENERGI-F703
Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers.
Placebo Comparator: Placebo
ENERGI-F703 matched vehicle, topical application, 2 times daily for 12 weeks
Drug: ENERGI-F703 matched vehicle
Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The ulcer closure rate
Time Frame: Week 12
Defined as the proportion of subjects with complete ulcer closure at the end of treatment period
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The accumulated confirmed ulcer closure rate at each of the post-treatment visit
Time Frame: Week 1, 2, 4 ,6 ,8, 10, 12
Week 1, 2, 4 ,6 ,8, 10, 12
The ulcer closure time
Time Frame: Week 1, 2, 4, 6, 8, 10, 12
Defined as the time to complete ulcer closure
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
Calculated as (Ulcer size at post treatment visit - Ulcer size at baseline)/(Ulcer size at baseline)
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
Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Energenesis Biomedical Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
A2 Healthcare Taiwan Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENERGI-F703-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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