Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Control Group: None (Utilize historical / published data on outcomes using standard of care)

Test Group: Treatment of DFUs with RestrataTM Wound Matrix

Study Type: Interventional

Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

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