A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer

NCT ID: NCT02667327

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2020-05-27

Brief Summary

The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers.

Detailed Description

DFU patients will undergo a one week screening period and those with changes in ulcer size of less than 30% will be eligible for randomization providing all other criteria are met. Participants enrolled in the study will receive treatment based on randomization into 1 of 3 treatment arms for up to 12 weeks. The participants will have an additional 12 week follow-up period beyond the treatment period to assess durability of wound closure.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Granexin gel plus Standard of Care

Granexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose.

Group Type: ACTIVE_COMPARATOR

Granexin gel

Intervention Type: DRUG

Granexin gel contains active pharmaceutical ingredient, aCT1 peptide, for topical application to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Vehicle gel plus Standard of Care

Vehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient.

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: OTHER

The vehicle gel formulation is hydroxyethyl cellulose that does not contain the active aCT1 peptide. Vehicle gel will be applied topically to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Standard of Care

Standard of Care includes cleaning and irrigating ulcer, non-surgical debridement, pain management, ulcer dressing, off-loading, and nutritional assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Granexin gel

Granexin gel contains active pharmaceutical ingredient, aCT1 peptide, for topical application to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Intervention Type: DRUG

Vehicle gel

The vehicle gel formulation is hydroxyethyl cellulose that does not contain the active aCT1 peptide. Vehicle gel will be applied topically to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Intervention Type: OTHER

Other Intervention Names

Granexin; Control

Eligibility Criteria

Inclusion Criteria

Both male and female participants may participate in the study.

1. Age 18 years or older

2. Established diagnosis of diabetes mellitus (type I or II)

3. Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit

4. Diagnosis of neuropathic foot ulcer by 10g monofilament test, tuning fork (128 Hz), or cotton wisp

5. Designated foot ulcer meets the following criteria at both the screening and baseline visits:

1. Present for at least 4 weeks

2. Full-thickness cutaneous ulcer below the ankle surface

3. University of Texas grade A1

4. Wound area (after debridement) 1 to 40.0 cm2

5. Viable, granulating wound (investigator discretion)

6. Ankle brachial index ≤ 0.7 at both the screening and baseline visits. If the ABI is >1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:

1. Does Not have a monophonic or biphasic flow (with the loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site.

2. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg

Additionally, patients must meet all other protocol-defined eligibility criteria.

7. Signed informed consent

8. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of investigational product. Male patients must also agree to use contraception such as a condom.

Exclusion Criteria

1. Change (decrease or increase) in size of the designated target ulcer by ≥ 30% during the 7-day screening period

2. Cannot tolerate the off-loading methods or cannot comply with study related procedures

3. Has an ulcer that meets any of the following criteria:

1. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site

2. Requires surgical debridement

3. Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure

4. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure

5. Is highly exuding (i.e., requires daily change of dressing)

4. Requires total contact cast

5. Ankle brachial pressure index < 0.7

6. Has a local or systemic infection or local lymphangitis ≥ 0.5 cm

7. Has any 1 of the following (only 1 of the 2 tests is required):

1. A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries

2. Transcutaneous oxygen pressure (TcPO2) at the foot <40 mgHg

8. Presence of active malignant or benign tumor of any kind, (with the exception to nonmelanoma skin cancer as per investigator's discretion)

9. Congestive heart failure (New York Heart Association class II-IV)

10. Coronary heart disease with ST segment elevation myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months

11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI

12. Active connective tissue disease

13. Acute or chronic Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination

14. Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids used for conditions other than treating the target ulcer or any area of the foot. Wash out period for systemic corticosteroids is 14 days for inclusion in this study. Wash out period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study)

15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for the inclusion in the study)

16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation

17. Pregnant or nursing mothers

18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)

19. Estimated glomerular filtration rate < 25 mL/min

20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)

21. Significant peripheral edema as per investigator's discretion

22. Known inability or unavailability of a patient to complete required study visits during study participation

23. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient's medical history, which, in the opinion of the investigator, may pose a threat to patient compliance

24. Use of a platelet-derived growth factor within 28 days before screening

25. Use of any investigational drug or therapy within 28 days before screening

26. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xequel Bio, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New Hope Podiatry Group, Inc.

Los Angeles, California, United States

Integral - Clinical Trials Solutions

Doral, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Nirvana Research Center

Miami, Florida, United States

Acclaim Bone & Joint

Fort Worth, Texas, United States

Futuro Clinical Trials, LLC

McAllen, Texas, United States

Centre podiatrique et soins des plaies

Boucherville, Quebec, Canada

Clinexpert Kft. - Kaszasdulo utca 5.

Budapest, , Hungary

Strazsahegy Medicina Bt., Zrinyi utca 226

Budapest, , Hungary

Shrey Hospital Pvt Ltd

Ahmedabad, Gujarat, India

Parul Sevashram Hospitals

Ahmedabad, Gujarat, India

Anand Multispecialty Hospital

Vadodara, Gujarat, India

Convenient Hospitals Ltd., CHL - Hospitals

Indore, Madhya Pradesh, India

KLEs Dr. Prabakar Kore Hospital and Medical Research Center

Belagavi, , India

Peoples College of Medical Science and Research Centre

Bhopal, , India

Marwari Hospital and Research Centre

Guwahati, , India

Surakshaka MultiSpecialty and Diabetes Hospital

Hyderabad, , India

KRM Hospital and Research Center

Lucknow, , India

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, , India

Fortis Hospital

Mohali, , India

K R Hospital and Research Institute

Mysore, , India

Supe Heart and Diabetes Hospital and Research Centre

Nashik, , India

Batra Hospital and Medical Research Center

New Delhi, , India

Aman Hospital and Research Centre

Vadodara, , India

Anu Hospitals, Kovelamudivara Street

Vijayawada, , India

Instytut Medycyny Wsi - oddz diabetologii ul. Jaczewskiego 2, 20-090 Lublin, Poland

Lublin, Jaczewskiego, Poland

NZOZ MED ART. Poradnie Specjalistyczne Ks. Wladyslawa 27, 44-240 Zory, Poland

Żory, Wladyslawa 27, Poland

Lubuskie Centrum Diabetologii UI.

Budziszynek, Zielon, Poland

MIKOMED Sp. z o.o. ul.

Lodz, Łódź .Pługowa, Poland

Countries

United States; Canada; Hungary; India; Poland

Other Identifiers

2015-DFU-301

Identifier Type: -

Identifier Source: org_study_id

NCT02666131

Identifier Type: -

Identifier Source: nct_alias