Diabetic Foot Ulcer
Conditions
Interventions
Product Name: Granexin® gel
Pharmaceutical Form: Gel
INN or Proposed INN: aCT1 peptide
Other descriptive name: aCT1 peptide
Concentration unit: µmole/ml micromole(s)/millilitre
Concentration type: equ
Sponsors
FirstString Research, Inc.
Eligibility
Sex/Gender
All
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 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 methods;Secondary Objective: 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 testing;Primary end point(s): Efficacy Endpoints The primary efficacy endpoint is the following: • Incidence of complete wound closure at Week 12 based on investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoint is the following: • Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period Other secondary efficacy endpoints are the following: • Incidence of complete wound closure at Week 24 (Month 6) based on investigator assessment • Mean percent wound reduction from baseline to Week 4 and Week 12 based on digital photographs • Incidence of wound recurrence for patients achieving complete closure based on investigator assessment • Clinical assessment of the target ulcer by the investigator • Incidence of amputation at or before Week 52 • 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 | — |
Countries
Canada, Hungary, India, Poland, United States
Contacts
Public ContactJános Bíró
BiTrial Clinical Research
Outcome results
None listed