New wound matrix shows promise for diabetic foot ulcers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female age 18 or older * Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement * Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA). * Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected * Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening * Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study * Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening: * HbA1c \< 12% * Serum Creatinine \< 3.0mg/dl * Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit: * Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR * ABIs with results of ≥0.7 and ≤1.5, OR * Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Exclusion Criteria: * Patients presenting with an ulcer probing to bone (UT Grade IIIA-D) * Patients whose index diabetic foot ulcers are greater than 25cm2 * Patient has an additional wound within 3cm of the study wound * Patients not in reasonable metabolic control * Patients with a known history of poor compliance with medical treatments * Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications * Patients with known or suspected local skin malignancy to the index diabetic ulcer * Patients diagnosed with autoimmune connective tissues diseases * Patients that have received a graft material on the study ulcer within the previous 30 days * Patients who are pregnant or breast feeding * Patients who are taking medications that are considered immune system modulator * Study wound has closed \> 30% over the two-week run-in period * Patients with a known allergy to resorbable suture materials