CompletedEarly Phase 1

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

United States111 participantsStarted 2022-07-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ankle Brachial Index (ABI) between 0.8 and 1.3
✓. Toe Brachial Index (TBI) \> 0.6
✓. Transcutaneous oximetry (TCOM) \>40mmHg
✓. Pulse volume recording (PVR): biphasic or triphasic waveforms

Exclusion criteria

✕. Heat lamps
✕. UV lights
✕. Whirlpool baths
✕. Hyperbaric oxygen
✕. Topical or local insulin administration
✕. Ankle Brachial Index (ABI) less than 0.7 or greater than 1.3
✕. Toe Brachial Index (TBI) \< 0.6
✕. Transcutaneous oximetry (TCOM) \<40mmHg

What they're measuring

Chronicity of Wound Healing

Timeframe: 4 weeks

Change in Wound Area

Timeframe: 4 weeks

Wound Healing

Timeframe: 4 weeks

Wound Closure

Timeframe: 12 weeks

Trial details

NCT IDNCT05921292

SponsorOmeza, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-22

View on ClinicalTrials.gov More Non-healing Wound trials