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
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
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.
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.
Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
Parallel
E-GRAFT ™
Other interventionE-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.
FIBRACOL™
Device510K FDA cleared Collagen alginate dressing
Comparison of the proportion of index ulcers "healed" at 12-weeks
Investigator assessment of healing (100% epithelization w/no drainage), measurements of ulcer size using manual measurements
Time to healing within 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
Digital imaging
Changes in peripheral neuropathy
Semmes Weinstein with vibratory, scores
Change in pain levels during trial
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."
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