Clinical Research Directory

Inclusion Criteria: 1. The subject has signed an IEC-approved study informed consent form 2. The subject is male or female, at least 18 years of age at the date of screening 3. The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus 4. The subject has a body mass index (BMI) of less than 40 kg/m2 5. The subject has an index ulcer with visible margins, having an area of ≥ 0.5 and ≤ 10.0 cm2 when measured by the electronic measuring device at screening 6. The index ulcer has been present for less than 12 months 7. The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot 8. The index ulcer does not extend beyond the subcutaneous tissue 9. The subject has an ABI \> 0.6 to \< 1.3 or TcPO2 ≥ 40 mmHg on the dorsum of the affected foot, or a great toe pressure ≥ 50 mmHg on the affected foot. Duplex ultrasound of the lower limb arteries is an acceptable alternative test but must show a peak systolic velocity ratio of \<2 for at least one of the posterior tibial, dorsalis pedis, and peroneal arteries. 10. The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test. 11. The subject is willing and able to return for all mandatory visits as defined in the protocol 12. The subject is willing and able to follow the instructions of the Investigator Exclusion Criteria: 1. The subject's index ulcer is primarily located on the dorsal surface of the foot 2. The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation 3. The subject has a contralateral major amputation of the lower extremity 4. The subject has more than 2 ulcers on the index foot (if there are two ulcers, the larger will be chosen as the index ulcer for treatment) 5. The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved) 6. The subject has a glycated hemoglobin (HbA1c) level of \> 8.0% (historical data may be used from within 6 months prior to screening) 7. The subject has been on oral steroid \> 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening 8. The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening 9. The subject is unable to sustain off-loading as defined by the protocol 10. The subject has an allergy to any component of the test article 11. The index ulcer is over an acute Charcot deformity 12. The subject is a member of a vulnerable population (e.g., prisoner, employee or family member of Sponsor or site staff, minor child, significant intellectual deficit) 13. Per Investigator's discretion the subject is not appropriate for inclusion in the investigation 14. Female patients who are pregnant or lactating