Diabetic Foot Ulcers (DFUs)
Conditions
Brief summary
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Changes in neuropathy (nerve damage) * Change in pain levels * Occurrence of infection
Detailed description
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available E-GRAFT™ that is a dehydrated thick amniotic allograft processed and approved for use as a Human Cellular and Tissue- Based Product (HCT/P) under FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act. In this trial, two groups of diabetic foot ulcers (DFUs) will receive standard of care (SOC) treatment for their condition. Half of the patients will receive a 510K FDA cleared Collagen alginate dressing FIBRACOL™ and the other half will have E-GRAFT™ dehydrated tissue allograft as the primary dressing. The primary endpoint is the percentage of patients that go on to complete closure of the target ulcer between the two groups: SOC with FIBRACOL™ or SOC with E-GRAFT™. Secondary endpoints include the proportion of subjects achieving complete wound closure of the target ulcer by the end of 12 weeks.
Interventions
Sponsors
Skye Biologics Holdings, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone. 7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit: 1. TCOM ≥30 mmHg 2. ABI between 0.7 and 1.3 3. PVR: Biphasic 4. TBI ˃0.6 5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle. 8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization. 10. The subject must consent to using the prescribed off-loading method for the duration of the study. 11. The subject must agree to attend the weekly study visits required by the protocol. 12. The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the proportion of index ulcers healed at 12-weeks | 12-weeks | Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to healing within 12-weeks | 12-weeks | Time to healing will be taken as the time of first assessment (i.e. before confirmation within two weeks) of complete healing. |
| Percentage Area Reduction over12 week period | 12-weeks | Digital imaging |
| Changes in peripheral neuropathy | 12-weeks | Semmes Weinstein with vibratory, scores |
| Change in pain levels during trial | 12-weeks | NPRS (Subject Pain Scale), 0-10: The number 0 represents no pain, the number 5 represents moderate pain, and the number 10 represents the worst possible pain. |
Countries
United States
Contacts
Primary ContactAdam Isaac, DPM
Backup ContactMelissa Crosswhite
Outcome results
None listed