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

Launched by PIOMIC MEDICAL · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment using the COMS One device for people with diabetic foot ulcers (DFUs) that have not healed well with standard care. The goal is to see if this device can help close the wounds more effectively compared to a dummy device (which looks the same but doesn't have the treatment). Participants will be followed for 12 weeks after using the device to see how well their ulcers heal.

To join the study, individuals must be between 22 and 90 years old, have type 1 or type 2 diabetes, and have a specific type of foot ulcer that has lasted between 30 and 52 weeks. They also need to be able to understand and sign the consent form and attend study visits. Participants can expect to receive care from the study team, who will monitor their progress and help with any questions or concerns. It's important to note that certain health conditions or treatments may prevent someone from participating, so the study team will review each case carefully.

Gender

ALL

Eligibility criteria

• 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 methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
• • 3. The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required 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 subject has more than one DFU that meets eligibility criteria, the investigator will designate 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 that same 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 after debridement at start of Run-In Phase)
• • 10. Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) 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-brachial index (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 with healing 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 30 days preceding and during the present trial
• • 7. Any co-morbid medical condition which places the subject at unreasonable risks in the 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 or any dose \>30 days
• • 10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization/Baseline Visit (measured post-debridement)
• • 11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization/Baseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization/Baseline Visit (measured post-debridement)
• 12. Blood chemistry or counts values as follows (based on subject's medical files):
• • 1. Pre-albumin \<10 mg/dL OR albumin \<2.8 g/dL
• • 2. Serum BUN \>60 mg/dL
• • 3. Serum creatinine \>4.0 mg/dL
• • 4. WBC \<2.0 x 109/L
• • 5. Hemoglobin \<8.0 g/dL
• • 6. Absolute neutrophil \<1.0 x 109/L
• • 7. Platelet count \<50 x 109/L
• • 8. HbA1C \>12%