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ENERGI-F703 for Diabetic Foot Ulcers Phase II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672436
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
A2 Healthcare Taiwan Corporation
Information provided by (Responsible Party):
Energenesis Biomedical Co., Ltd.

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of ENERGI-F703 in subject with diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Foot Ulcer Diabetes Mellitus Wounds Drug: ENERGI-F703 Drug: ENERGI-F703 matched vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : October 3, 2019
Actual Study Completion Date : December 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. The ulcer closure rate [ Time Frame: Week 12 ]
    Defined as the proportion of subjects with complete ulcer closure at the end of treatment period


Secondary Outcome Measures :
  1. The accumulated confirmed ulcer closure rate at each of the post-treatment visit [ Time Frame: Week 1, 2, 4 ,6 ,8, 10, 12 ]
  2. The ulcer closure time [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12 ]
    Defined as the time to complete ulcer closure

  3. 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)

  4. Adverse event incidence [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672436


Locations
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Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Energenesis Biomedical Co., Ltd.
A2 Healthcare Taiwan Corporation
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Responsible Party: Energenesis Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02672436    
Other Study ID Numbers: ENERGI-F703-01
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Energenesis Biomedical Co., Ltd.:
Diabetic Foot Ulcer
Diabetes Mellitus
Wound Healing
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases