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

About

Brief Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

22 Years

Maximum Age

90 Years

Inclusion Criteria:

Subjects are male or female, ≥22 and ≤90 years of age
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.
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)
Type 1 or Type 2 diabetes mellitus
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)
Wagner Grade 1 or 2 (without bone exposure)
There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
Target DFU duration >30 days and <52 weeks
Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
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:

Known pregnancy or lactating
Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
Wagner Grade 3, 4 or 5
Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
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
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)
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)
Blood chemistry or counts values as follows (based on subject's medical files):
- Pre-albumin <10 mg/dL OR albumin <2.8 g/dL
- Serum BUN >60 mg/dL
- Serum creatinine >4.0 mg/dL
- WBC <2.0 x 109/L
- Hemoglobin <8.0 g/dL
- Absolute neutrophil <1.0 x 109/L
- Platelet count <50 x 109/L
- HbA1C >12%