Diabetic Foot Ulcers
Conditions
Keywords
diabetic foot ulcer, diabetic complications, diabetes, wound healing, Granexin gel, FirstString Research
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.
Interventions
DRUGGranexin 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.
OTHERVehicle 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.
Sponsors
Xequel Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complete wound closure at Week 12 based on investigator assessment | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period | Week 12 |
Countries
Canada, Hungary, India, Poland, United States
Outcome results
None listed