NCT05921292

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

A Clinical Study to Evaluate the Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Omeza, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is: \- Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period? Patients will be treated with: * OCM™ Wound Matrix * Omeza combination therapy * Standard of Care

Detailed description

The goal of this clinical trial is to demonstrate that the Omeza combination therapy with Standard of Care supports chronic wounds to move from chronicity to a healing trajectory. The trial is targeting those wounds that have failed therapy prior to trial enrollment and are chronic by definition of no change in area size after 2 weeks of standard of care treatment. The inclusion and exclusion criteria applied to this chronic wound clinical trial is broadened with the intention to include all patients and outliers that would not qualify for controlled trials.

Conditions

• Non-healing Wound
• Non-Healing Ulcer of Skin

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-11
• Primary completion: 2024-01-22
• Completion: 2024-05-31
• First posted: 2023-06-27
• Last updated: 2024-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study