Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

Inclusion Criteria:

1. Subjects are male or female, ≥22 and ≤90 years of age

2. Female subjects of childbearing potential must be willing to use acceptable methodsof contraception (birth control pills, barriers, or abstinence) starting atscreening and throughout the duration of their study participation.

3. The participant (or LAR if applicable) must be able to understand and sign theinformed consent form (ICF) and comply with requirements set in the protocolincluding trial visits, trial treatment and dressing regimens and compliance withrequired offloading device (if applicable)

4. Type 1 or Type 2 diabetes mellitus

5. Presence of one full-thickness DFU located at or below the malleoli (If the subjecthas more than one DFU that meets eligibility criteria, the investigator willdesignate one DFU as the target DFU to be treated in the trial)

6. Wagner Grade 1 or 2 (without bone exposure)

7. There is a minimum 2 cm margin between the target DFU and any other ulcer on thatsame foot, post-debridement

8. Target DFU duration >30 days and <52 weeks

9. Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 afterdebridement at start of Run-In Phase)

10. Adequate vascular perfusion of the target limb (same limb as where the target DFU islocated) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) >0.7 but less than 1.2 or a toe-brachialindex (TBI) >0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) >40mmHg

Exclusion Criteria:

1. Known pregnancy or lactating

2. Active skin cancer, a history of skin cancer or any other localized cancer,precancerous lesions or large moles in the areas to be treated.

3. Subject who is taking any medications the Investigator believes may interfere withhealing of the target DFU

4. Subject who is currently undergoing treatment for an active systemic infection,including osteomyelitis

5. Wagner Grade 3, 4 or 5

6. Participation in another trial with investigational drug or device within the 30days preceding and during the present trial

7. Any co-morbid medical condition which places the subject at unreasonable risks inthe opinion of the Investigator

8. Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)

9. Subject is being treated with systemic corticosteroids (prednisone, dexamethasone,hydrocortisone, methylprednisolone, or similar) >10mg/day for more than 10 days orany dose >30 days

10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU atScreening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50%closure of target DFU between the 2 Week Historical Period andRandomization/Baseline Visit (measured post-debridement)

11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU atScreening Run-In Visit II or between Screening Run-In Phase Visit II andRandomization/Baseline Visit or more than 50% closure of target DFU betweenScreening Run-In Phase Visit I and Randomization/Baseline Visit (measuredpost-debridement)

12. Blood chemistry or counts values as follows (based on subject's medical files):

13. Pre-albumin <10 mg/dL OR albumin <2.8 g/dL

14. Serum BUN >60 mg/dL

15. Serum creatinine >4.0 mg/dL

16. WBC <2.0 x 109/L

17. Hemoglobin <8.0 g/dL

18. Absolute neutrophil <1.0 x 109/L

19. Platelet count <50 x 109/L

20. HbA1C >12%