ENERGI-F703 for Diabetic Foot Ulcers Phase II Study

Sponsor

Energenesis Biomedical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02672436

Collaborator

A2 Healthcare Taiwan Corporation (Industry)

141

Enrollment

Location

Arms

33.4

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Mar 15, 2017

Actual Primary Completion Date :

Oct 3, 2019

Actual Study Completion Date :

Dec 26, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The ulcer closure rate [Week 12]
Defined as the proportion of subjects with complete ulcer closure at the end of treatment period

Secondary Outcome Measures

The accumulated confirmed ulcer closure rate at each of the post-treatment visit [Week 1, 2, 4 ,6 ,8, 10, 12]
The ulcer closure time [Week 1, 2, 4, 6, 8, 10, 12]
Defined as the time to complete ulcer closure
Percentage change in ulcer size for each post-treatment visit [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)
Adverse event incidence [Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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