A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's

Exclusion Criteria

• •1\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• •2\. 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.
• •3\. Index ulcer is overtly infected (i.e. purulent drainage). 4. Subjects with a history of more than two weeks of 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.
• •5\. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
• •6\. History of radiation at the ulcer site (regardless of time since last radiation treatment).
• •7\. Index ulcer has been previously treated or will need to be treated with any prohibited therapies.
• •8\. Subjects with a previous diagnosis of HIV or Hepatitis C. 9. 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.
• •10\. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• •11\. Subject is pregnant or breast-feeding. 12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days.
• •13\. Subjects with end-stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization. 14. Presence of active Charcot Neuroarthropathy to the affected limb. 15. Any wound located entirely on the medial or lateral border of the foot. 16. Any wound located between the 1st through 4th toe interspaces. 17. Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit.