Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Granexin: Investigational products (Granexin gel or vehicle gel) will be dispensed directly from a provided 5 gram laminate tube, and a sterile applicator will be used to apply a unifor
Sponsors
FirstString Research Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Established diagnosis of diabetes mellitus (type I or II) 3. Glycosylated hemoglobin (HbA1c) value 4. Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork, 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.
Exclusion criteria
Exclusion criteria: 1. Change (decrease or increase) in size of the designated target ulcer by greater than or equal to 30 percent 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 β-hemolytic streptococci upon culture performed prior to screening debridement procedure. d. Has greater than 50 percent 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 less than 0.7 6. Has a local or systemic infection or local lymphangitis greater than or equal to 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 less than 40 mmHg 8. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigatorâ??s discretion) 9. Congestive heart failure (New York Heart Association class IIâ??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 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 19. Estimated glomerular filtration rate 20. Poor nutritional status, defined as an albumin 21. Significant peripheral edema as per investigatorâ??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 medical history, which, in the opinion of the investigator, may pose a threat to patient compliance 24.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, as measured by investigator assessment of wound closure and by other methodTimepoint: At Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complete wound closureTimepoint: at Week 24 (Month 6) based on investigator assessment;To evaluate the safety of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, by standard methods and immunogenicity testingTimepoint: Over the 12 week treatment period | — |
Countries
Canada, Czech Republic, Hungary, India, Poland, United States of America
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed