Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers

Part of paid clinical trials in Evergreen Park, Illinois.

Sponsor
Omeza, LLC
Study ID
NCT07161830
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Study Details

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.

Key Dates

First listed
Sep 9, 2025
Start date
Dec 4, 2025
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OCM + SOC
    Omeza® Complete Matrix (OCM™) is a wound care matrix comprised of hydrolyzed fish collagen derived from whitefish skin
  • Active Comparator: Standard of Care
    Surgical sharp debridement, offloading (TCC gold standard, fixed ankle-walker alternative), and proper moisture balance

Primary Outcome Measure

Complete Wound Closure [ Time Frame: 1-12 weeks ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
SitePath ResearchEvergreen ParkIllinois60805
Ana Petrovic
[email protected]
Bela Pandit, DPM (PRINCIPAL_INVESTIGATOR)
MedCentris of Denham SpringsDenham SpringsLouisiana70726
Tabatha Yent, LPN
[email protected]
Monique Consoer, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of LeesvilleLeesvilleLouisiana71446
Brandi Shuff, LPN
[email protected]
Stefanie Corley, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of MarksvilleMarksvilleLouisiana71351
Laura Whittington
[email protected]
Averie Rachal, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of SlidellSlidellLouisiana70458
Donyille Singletary, RN
[email protected]
Natalie Dean, FNP (PRINCIPAL_INVESTIGATOR)
MedCentris of VidaliaVidaliaLouisiana71373
Taylor Estis
[email protected]
Shanda Jackson, NP (PRINCIPAL_INVESTIGATOR)
MedCentris of ClevelandClevelandMississippi38732
Paige Livingston
[email protected]
Shauna Allen, FNP (PRINCIPAL_INVESTIGATOR)
MedCentris of SouthavenSouthavenMississippi38671
Juliase Walls, LPN
[email protected]
Carlene McAllister, NP (PRINCIPAL_INVESTIGATOR)
Gentle Foot CareNewarkOhio43055
Mandy Wilson
[email protected]
Jeffrey Wilson, DPM (PRINCIPAL_INVESTIGATOR)
Gentle Foot CareSylvaniaOhio43560
Betsy Naugle
[email protected]
Gregory Black, DPM (PRINCIPAL_INVESTIGATOR)

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By research site
SitePath Research· Evergreen Park, ILMedCentris of Denham Springs· Denham Springs, LAMedCentris of Leesville· Leesville, LAMedCentris of Marksville· Marksville, LAMedCentris of Slidell· Slidell, LAMedCentris of Vidalia· Vidalia, LA

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