Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer

The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.

Inclusion Criteria:

1. Patient is at least 18 years old

2. Patient is willing and capable of complying with all protocol requirements

3. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period

4. Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)

5. Ulcer must be located at least in part on the foot or ankle

6. Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product

7. Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement

8. Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:

   1. Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
   2. Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
   3. Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg

Exclusion Criteria:

1. Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
2. Patient is pregnant, breast feeding or planning to become pregnant
3. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
4. Patient has a life expectancy less than six months as assessed by the investigator
5. Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
6. Patient has an additional wound within 3 cm of the study wound
7. Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
8. Patient not in reasonable metabolic control in the judgment of the investigator
9. Patient with a known history of poor compliance with medical treatments
10. Patient currently undergoing cancer treatment
11. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
12. Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period. Chronic oral steroid use is not excluded if dose is < 10 mg per day for prednisone.
13. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgment of the investigator
14. Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
15. Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
16. Study ulcer spontaneously closes during the 2-week run in period