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