The Omeza Protocol for Chronic Ulcers

Inclusion Criteria:

1. Male or female 21-80 years of age
2. Participated in the informed consent process and signed study specific informedconsent document
3. Willing and able to comply with study procedures, including study visits and studydressing regimens
4. 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
5. HbA1c of ≤ 10%
6. Have a venous ulcer between the knee and ankle, at or above the malleolus
7. 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 debridementat Screening Visit and Treatment Visit Week 1/Randomization
8. Target wound duration of at least 3 months and less than or equal to 12 months as ofthe date the subject signs consent for study
9. Containing yellow/white slough with or without fibrous/scar tissue and/or non- viabletissue
10. Be willing and able (or have family member/friend willing and able) to apply requireddressing changes as well as the ability of the subject to tolerate limb compressionbandage
11. Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3

Exclusion Criteria:

1. Subjects with a BMI ≥ 65
2. Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitivelyimpaired (due to being mentally challenged, having Alzheimer