The Omeza Protocol for Chronic Ulcers
Status unconfirmed · Not applicable
Conditions studied: Venous Leg Ulcer, Diabetic Foot Ulcer
In brief
This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.
Key facts
- Study ID
- NCT04198441
- Run by
- Omeza, LLC
- People needed
- 78
- Starts
- 2020-06-02
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-04-09
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female 21-80 years of age
- Participated in the informed consent process and signed study specific informed consent document
- Willing and able to comply with study procedures, including study visits and study dressing regimens
- Confirmation of venous disease by non-invasive venous studies with either Doppler- confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g. cancer on ulcers ≥ 6 months
- HbA1c of ≤ 10%
- Have a venous ulcer between the knee and ankle, at or above the malleolus
- For VLU's: Target wound size ≥ 4 cm2 to ≤ 150 cm2 in area without exposed tendon, muscle or bone For DFU's: Target wound size ≥ 0.25 cm2 to ≤ 150 cm2 post debridement at Screening Visit and Treatment Visit Week 1/Randomization
- Target wound duration of at least 3 months and less than or equal to 12 months as of the date the subject signs consent for study
- Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue
- Be willing and able (or have family member/friend willing and able) to apply required dressing changes as well as the ability of the subject to tolerate limb compression bandage
- Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3
You may not qualify if…
- Subjects with a BMI ≥ 65
- Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer
Where it is running
- First Coast Cardiovascular Institute — Jacksonville, Florida, United States (enrolling)
- Saint Michael's Medical Center — Newark, New Jersey, United States (enrolling)
- Oregon Health & Science University (OHSU) — Portland, Oregon, United States (enrolling)
- Baylor Scott & White Comprehensive Wound Care Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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