Clinical trial NCT02667327: A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot Ulcers
Keywords: diabetic foot ulcer
diabetic complications
diabetes
wound healing
Granexin gel
FirstString Research
Lead sponsor: Xequel Bio, Inc.
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Incidence of complete wound closure at Week 12 based on investigator assessment
timeFrame: Week 12
Secondary outcomes:
measure: Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period
timeFrame: Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: New Hope Podiatry Group, Inc.
state: California
city: Doral
country: United States
facility: Integral - Clinical Trials Solutions
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: Nirvana Research Center
state: Florida
city: Fort Worth
country: United States
facility: Acclaim Bone & Joint
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: Boucherville
country: Canada
facility: Centre podiatrique et soins des plaies
state: Quebec
city: Budapest
country: Hungary
facility: Clinexpert Kft. - Kaszasdulo utca 5.
city: Budapest
country: Hungary
facility: Strazsahegy Medicina Bt., Zrinyi utca 226
city: Ahmedabad
country: India
facility: Shrey Hospital Pvt Ltd
state: Gujarat
city: Ahmedabad
country: India
facility: Parul Sevashram Hospitals
state: Gujarat
city: Vadodara
country: India
facility: Anand Multispecialty Hospital
state: Gujarat
city: Indore
country: India
facility: Convenient Hospitals Ltd., CHL - Hospitals
state: Madhya Pradesh
city: Belgaum
country: India
facility: KLEs Dr. Prabakar Kore Hospital and Medical Research Center
city: Bhopal
country: India
facility: Peoples College of Medical Science and Research Centre
city: Guwahati
country: India
facility: Marwari Hospital and Research Centre
city: Hyderabad
country: India
facility: Surakshaka MultiSpecialty and Diabetes Hospital
city: Lucknow
country: India
facility: KRM Hospital and Research Center
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
city: Mohali
country: India
facility: Fortis Hospital
city: Mysore
country: India
facility: K R Hospital and Research Institute
city: Nashik
country: India
facility: Supe Heart and Diabetes Hospital and Research Centre
city: New Delhi
country: India
facility: Batra Hospital and Medical Research Center
city: Vadodara
country: India
facility: Aman Hospital and Research Centre
city: Vijayawada
country: India
facility: Anu Hospitals, Kovelamudivara Street
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi - oddz diabetologii ul. Jaczewskiego 2, 20-090 Lublin, Poland
state: Jaczewskiego
city: Zory
country: Poland
facility: NZOZ MED ART. Poradnie Specjalistyczne Ks. Wladyslawa 27, 44-240 Zory, Poland
state: Wladyslawa 27
city: Budziszynek
country: Poland
facility: Lubuskie Centrum Diabetologii UI.
state: Zielon
city: Łódź .
country: Poland
facility: MIKOMED Sp. z o.o. ul.
state: Łódź .Pługowa
Study officials:
References: