The Omeza Protocol for Chronic Ulcers

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198441
• Other study ID #: Protocol Number: 100
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Omeza, LLC
• Contact: Luba Lavrik
• Phone: 561-200-3344
• Email: LLavrik[@]PalmBeachCRO.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Wound dressing
Clean wound, fill wound, dress wound

Locations

Country	Name	City	State
United States	Baylor Scott & White Comprehensive Wound Care Center	Dallas	Texas
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Oregon Health & Science University (OHSU)	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Omeza, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure	Percent wound closure from baseline	13 weeks
Primary	Wound Closure Rate	Rate of wound closure measured weekly	13 weeks
Primary	Time to Maximum Wound Closure	Number of weeks to achieve complete wound closure	1-13 weeks