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

Diabetic Foot Ulcers Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle Controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02667327
• Other study ID #: 2015-DFU-301
• Status: Terminated
• Phase: Phase 3
• Start date: November 21, 2018
• Est. completion date: May 27, 2020

Study information

• Verified date: May 2020
• Source: FirstString Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT02666131

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Both male and female participants may participate in the study.

To be eligible for entry into this study, a patient must meet all of the following Inclusion criteria:

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:

Patients will not be eligible for enrollment in the study if they meet any of the exclusion criterial listed below:

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 ß-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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Canada	Centre podiatrique et soins des plaies	Boucherville	Quebec
Hungary	Clinexpert Kft. - Kaszasdulo utca 5.	Budapest
Hungary	Strazsahegy Medicina Bt., Zrinyi utca 226	Budapest
India	Parul Sevashram Hospitals	Ahmedabad	Gujarat
India	Shrey Hospital Pvt Ltd	Ahmedabad	Gujarat
India	KLEs Dr. Prabakar Kore Hospital and Medical Research Center	Belgaum
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	Convenient Hospitals Ltd., CHL - Hospitals	Indore	Madhya Pradesh
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	Anand Multispecialty Hospital	Vadodara	Gujarat
India	Anu Hospitals, Kovelamudivara Street	Vijayawada
Poland	Lubuskie Centrum Diabetologii UI.	Budziszynek	Zielon
Poland	MIKOMED Sp. z o.o. ul.	Lódz .	Lódz .Plugowa
Poland	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	Zory	Wladyslawa 27
United States	Integral - Clinical Trials Solutions	Doral	Florida
United States	Acclaim Bone & Joint	Fort Worth	Texas
United States	Direct Helpers Research Center	Hialeah	Florida
United States	New Hope Podiatry Group, Inc.	Los Angeles	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	Nirvana Research Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
FirstString Research, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  India,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete wound closure at Week 12 based on investigator assessment		Week 12
Secondary	Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period		Week 12