Multicenter Study of the Efficacy and Safety of Granexin Gel in theTreatment of Diabetic Foot Ulcer (GAIT 1)
- Conditions
- Diabetic Foot UlcerTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001725-75-HU
- Lead Sponsor
- FirstString Research, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 552
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 10 g monofilament test, tuning fork (128 Hz), or cotton wisp
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. Wound area (after debridement) 1 to 40.0 cm2
e. 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:
a. Does not have 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, as determined by standard practices of the investigator and the site.
b. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 152
1. Change (decrease or increase) in size of the designated target ulcer by = 30% during the 7-day screening period
2. Cannot tolerate off-loading methods or cannot comply with study related procedures
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 surgical debridement
c. Is positive for ß-hemolytic streptococci upon culture performed prior to screening debridement procedure.
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
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):
a. 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
b. Transcutaneous oxygen pressure (TcPO2) at the foot < 40 mmHg
8. Presence of active malignant or benign tumors of any kind, (with 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, 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 or topical 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 the 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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To evaluate the efficacy of Granexin gel plus standard-of-care in the<br>treatment of diabetic foot ulcer, as compared with vehicle gel plus<br>standard-of-care and with standard-of-care treatment alone, as<br>measured by investigator assessment of wound closure and by other methods;Secondary Objective: To evaluate the safety of Granexin gel plus standard-of-care in the<br>treatment of diabetic foot ulcer, as compared with vehicle gel plus<br>standard-of-care and with standard-of-care treatment alone, by<br>standard methods and immunogenicity testing;Primary end point(s): Efficacy Endpoints<br>The primary efficacy endpoint is the following:<br>• Incidence of complete wound closure at Week 12 based on<br>investigator assessment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The key secondary efficacy endpoint is the following:<br>• Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period<br>Other secondary efficacy endpoints are the following:<br>• Incidence of complete wound closure at Week 24 (Month 6) based on investigator assessment<br>• Mean percent wound reduction from baseline to Week 4 and Week 12 based on digital photographs<br>• Incidence of wound recurrence for patients achieving complete closure based on investigator assessment<br>• Clinical assessment of the target ulcer by the investigator<br>• Incidence of amputation at or before Week 52<br>• Change from baseline in 12 domain scores of the DFS at Week 12;Timepoint(s) of evaluation of this end point: Day 0 - Week 52