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

This trial does not accept healthy volunteers

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 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

Design model

Parallel

Treatments tested in this trial

Omeza® Complete Matrix
Device
OCM Application, Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance
Standard of Care
Other intervention
Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: OCM + SOCExperimental treatment 1 intervention

Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

Complete Wound Closure

The primary endpoint will be the percentage of target ulcers that achieve complete wound closure within 12 weeks.

Time frame

1-12 weeks

Secondary outcomes

Percentage Wound Area Change

The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.

Time frame

1-12 weeks

Pain Assessment

Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale throughout the study. The Numeric Pain Rating Scale is measured between 0-10. 0 being no pain at all and 10 being the worst pain.

Time frame

1-12 weeks

Other outcomes

Hemoglobin A1c

Incidence of wound closure vs HbA1c \>10, 12, 15

Time frame

1-16 weeks

Time to Closure

Average number of grafts/weeks used to achieve wound closure

Time frame

1-12 weeks

Follow-Up Closure

Number of wounds that re-opened during the 2-week follow-up

Time frame

2-weeks

Adverse Events and Serious Adverse Events

The number and nature of adverse events (AEs) and serious adverse events (SAEs) occurring during the study will be tracked and reported.

Time frame

1-16 weeks

Sponsors and contacts

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Omeza, LLC

Lead sponsor

SygNola, LLC

Collaborator

Source ClinicalTrials.gov

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