A Study of Granexin Gel to Treat Diabetic Foot Ulcer

Diabetic Foot Ulcers Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Parallel-group, Multicenter Study Investigating the Safety and Efficacy of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02666131
• Other study ID #: 2015-DFU-302
• Status: Recruiting
• Phase: Phase 3
• First received: January 25, 2016
• Last updated: February 6, 2018
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: FirstString Research, Inc.
• Contact: Gautam S. Ghatnekar, Ph.D.
• Email: info[@]firststringresearch.com
• 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 2 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

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

3. Glycosylated hemoglobin (HbA1c) value < 10.0% at the screening visit

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

5. Designated foot ulcer meets the following criteria at both the screening and baseline visits:a. Present for at least 4 weeks; b. Full-thickness cutaneous ulcer below the ankle surface; c. University of Texas grade A1; d. Diameter (after debridement) 1 to 40.0 cm2; e. Viable, granulating wound (investigator discretion)

6. Ankle brachial index 0.7 to 1.3 at both the screening and baseline visits

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 study drug

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 method or cannot comply with study-defined standard-of-care treatment

3. Has an ulcer that meets any of the following criteria: a. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site; b. Requires operative debridement; c. Is positive for ß-hemolytic streptococci upon culture; d. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure; e. Is highly exuding (i.e., requires daily change of dressing)

4. Requires total contact cast

5. Ankle brachial pressure index < 0.7 or > 1.3 or ankle systolic pressure < 70 mmHg

6. Has a local or systemic infection or local erythema = 0.5 cm

7. Has any 1 of the following (only 1 of the 3 tests is required): a. On Doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, a monophasic or biphasic flow (with loss of reverse flow) in either the artery of either foot; b. Toe:brachial index < 0.75 or > 1.3

c. Transcutaneous oxygen pressure < 40 mmHg

8. Presence of active systemic or local cancer or tumor of any kind (exception:

nonmelanoma skin cancer allowable at investigator discretion)

9. Congestive heart failure (New York Heart Association class II-IV) or coronary heart disease with ST segment elevation myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months

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

11. Active connective tissue disease

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

13. Active treatment with systemic corticosteroids

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

15. Pregnant or nursing

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

17. Estimated glomerular filtration rate < 25 mL/min

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

19. Significant peripheral edema as per investigator's discretion

20. Known inability or unavailability to complete required study visits during study participation

21. 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

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

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

24. 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.
• 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
United States	Aiyan Diabetes Center	Augusta	Georgia
United States	Spartanburg Regional Health System	Spartanburg	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
FirstString Research, Inc.	INC Research, Medical University of South Carolina

Country where clinical trial is conducted

United States, 

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