The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with 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) * Change in pain levels * Occurrence of infection
Subjects must be at least 18 years of age or older.
At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.
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.
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
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.
The target ulcer must be full thickness on the foot or leg that does not probe to bone.
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 over 12 week period
Digital imaging
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