Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Exclusion Criteria

• •Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• •Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• •Subjects with a history of more than two weeks treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
• •Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
• •Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
• •History of radiation at the ulcer site (regardless of time since last radiation treatment).
• •Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
• •Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• •Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• •Subject is pregnant or breast-feeding.
• •Presence of diabetes with poor metabolic control as documented with an HbA1c \> 12.0 within 90 days of randomization.
• •Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
• •Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.