Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOmeza, LLC
About this trial
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.
Eligibility criteria
Qualifiers
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
Disqualifiers
Subject has a known life expectance of <1 year
Subject is unable to comply with protocol treatment
Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
Trial design
Treatments tested in this trial
- Omeza® Complete Matrix
- Standard of Care
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Omeza, LLC
Lead sponsor
SygNola, LLC
Collaborator
Source ClinicalTrials.gov