About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the time of completion of screening to either Symphony™ treatment or Standard of Care (SOC) treatment groups.
Following initial enrolment, eligible subjects will then undergo:
A screening phase consisting of 14 days to determine eligibility.
Eligible subjects will then undergo a treatment phase involving weekly treatment and evaluations for up to 12 weeks.
Subjects that heal will undergo a follow-up phase that includes 1 visit (Healing Confirmation Visit), 2 weeks from initial healing.
If the subject does not heal, they will exit at Week 13, End of Study visit.
Both treatment groups will receive accepted routine procedures being part of SOC, including offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject’s foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and infection management.
In addition to what is noted above, Group 1 will receive a weekly application of Symphony™ and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4×4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3layer or equivalent) applied.
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