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

Inclusion criteria

• ✓. At least 18 years old, inclusive.
• ✓. Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions) on the plantar or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.
• ✓. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• ✓. Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
• ✓. Index ulcer is a minimum of 0.8 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• ✓. Within 3 months of SV1, adequate circulation to the affected foot, as documented by a 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 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
• ✓. The target ulcer has been offloaded for at least 14 days prior to randomization.
• ✓. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.