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

Inclusion Criteria:

1. At least 18 years old, inclusive.

2. Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions) on the plantar ordorsal aspect of the foot, extending through the dermis provided it is below themedial aspect of the malleolus.

3. The index ulcer will be the largest ulcer if two or more DFUs are present with thesame Wagner grade and will be the only one evaluated in the study. If otherulcerations are present on the same foot, they must be more than 2 cm distant fromthe index ulcer.

4. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4weeks prior to SV1 and less than 1 year, as of the date the subject consents forstudy.

5. Index ulcer is a minimum of 0.8 cm2 and a maximum of 25 cm2 at SV1 and TV1.

6. Within 3 months of SV1, adequate circulation to the affected foot, as documented bya dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP)measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3within 3 months of SV1, using the affected study extremity. As an alternativearterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedisand posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index)of > 0.6 is acceptable.

7. The target ulcer has been offloaded for at least 14 days prior to randomization.

8. Females of childbearing potential must be willing to use acceptable methods ofcontraception (birth control pills, barriers or abstinence) during the course of thestudy and undergo pregnancy tests.

9. Subject understands and is willing to participate in the clinical study and cancomply with weekly visits.

10. Subjects must have read and signed the IRB approved ICF before screening proceduresare performed.

Exclusion Criteria:

1. Index ulcer(s) deemed by the investigator to be caused by a medical conditionother than diabetes.

2. Index ulcer, in the opinion of the investigator, is suspicious for cancer andshould 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 ahistory of more than two weeks of treatment with immune-suppressants (includingsystemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, orapplication of topical steroids to the ulcer surface within 1-month prior tofirst SV1, or who receive such medications during the screening period or whoare anticipated to require such medications during the course of the study.

4. Subjects on any investigational drug(s) or therapeutic device(s) within 30 dayspreceding SV1.

5. History of radiation at the ulcer site (regardless of time since last radiationtreatment).

6. Index ulcer has been previously treated or will need to be treated with anyprohibited therapies.

7. Subjects with a previous diagnosis of HIV or Hepatitis C. 9. Presence of anycondition(s) which seriously compromises the subject's ability to complete thisstudy or has a known history of poor adherence with medical treatment.

8. Osteomyelitis or bone infection of the affected foot as verified by x-raywithin 30 days prior to the first screening visit. (In the event of anambiguous diagnosis, the Principal Investigator will make the final decision).

9. Subject is pregnant or breast-feeding. 12. Presence of diabetes with poormetabolic control as documented with an HbA1c >12.0 within last 90 days.

10. Subjects with end-stage renal disease as evidenced by a serum creatinine ≥3.0mg/dL within 6 months of randomization. 14. Presence of active CharcotNeuroarthropathy to the affected limb. 15. Any wound located entirely on themedial or lateral border of the foot. 16. Any wound located between the 1stthrough 4th toe interspaces. 17. Index ulcer has reduced in area by 30% or moreafter 14 days of SOC from SV1 to the TV1/Randomization visit.