Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

July 11, 2022

Primary Completion Date

January 22, 2024

Study Completion Date

May 31, 2024

Conditions
Non-healing WoundNon-Healing Ulcer of Skin
Interventions
COMBINATION_PRODUCT

Omeza Products Used in Combination

"Subjects in this single-arm study will have the targeted wound/ulcer treated with Omeza® combination therapy which includes the use of the following products:~* Omeza® Lidocaine Lavage~* Omeza® Complete Matrix (OCM™)~* Omeza® Skin Protectant At each treatment (on days 0, 7, 14, 21; +/- 3 days each), the patient's intact skin around the wound/ulcer will be prepped with Omeza® Lidocaine Lavage. OCM™ will be applied directly to the wound/ulcer and Omeza® Skin Protectant will be applied to the periwound and surrounding intact skin. Treatments may be repeated during an optional 7 additional weeks (on days 28, 35, 42, 49, 56, 63, and 70; +/- 3 days each). Final assessment will be made at week 12."

Trial Locations (1)

87505

Christus St. Vincent, Santa Fe

All Listed Sponsors
lead

Omeza, LLC

INDUSTRY