Clinical trial NCT04198441: The Omeza Protocol for Chronic Ulcers
Official title: A Randomized, Multicenter, Open Label Study Comparing the Omeza® Products Bundle to Standard of Care for Chronic Venous Leg Ulcers and Chronic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Diabetic Foot Ulcer
Lead sponsor: Omeza, LLC
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a randomized, multi-center, open-label study comparing the Omeza® Products Bundle versus standard of care treatments for 2 different types of chronic ulcers (venous leg ulcers and diabetic foot ulcers). The treatment period will be 12 weeks, with subjects coming into the study site weekly for evaluations, photography and formal measurements of the target wound, and dressing changes. There will be a total of 13 study site visits. The Screening Visit (Day 0) will occur 1 week prior to randomization and will include routine labs and vascular assessment to determine inclusion/exclusion of the potential subject from the study; followed by weekly treatment visits (Week 1 through Week 11); randomization will occur at Treatment Visit Week 1; the Treatment Visit Week 12/End of Study Visit will include end of study labs. Target wounds will be photographed and measured, and vascular assessment will be done at each of the 13 visits.

If the wound closes before Week 12, the subject will continue to come in for all the remaining study visits until study completion. If the wound does not close by Week 12, the subject will be immediately exited from the study and no further follow-up will occur as part of the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female 21-80 years of age
2. Participated in the informed consent process and signed study specific informed consent document
3. Willing and able to comply with study procedures, including study visits and study dressing 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 debridement at 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 of the date the subject signs consent for study
9. Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue
10. 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
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 cognitively impaired (due to being mentally challenged, having Alzheimer

Primary outcomes:
measure: Wound Closure
timeFrame: 13 weeks
measure: Wound Closure Rate
timeFrame: 13 weeks
measure: Time to Maximum Wound Closure
timeFrame: 1-13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Dallas
country: United States
facility: Baylor Scott & White Comprehensive Wound Care Center
state: Texas
Study officials:
affiliation: Baylor University Medical Center's Comprehensive Wound Center
name: Andrew J Applewhite, MD,CWSP,FUHM
role: PRINCIPAL_INVESTIGATOR
affiliation: First Coast Cardiovascular Institute
name: David Swain, DPM,CWSP
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Robert B McLafferty, MD,MBA,FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Michael's Medical Center
name: Jacob Reinkraut, DPM,FACFAS
role: PRINCIPAL_INVESTIGATOR
References: