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Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:
A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers

Clinical Trial Summary

This study is to evaluate the efficacy of Omeza® Lidocaine Lavage, Omeza® Collagen Matrix and Omeza® Skin Protectant used in combination with off-loading devices for the treatment of diabetic foot ulcers.

Clinical Trial Description

The study will have three phases: screening, treatment and healing confirmation. The screening phase is to determine eligibility of subjects and chronicity of the diabetic foot ulcer and will include off-loading. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects will be treated weekly with the Omeza combination therapy and standard of care to continue offloading. At the conclusion of the 4 weekly treatments, healing will be assessed and continued therapy will be at the PI's discretion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05417425
Study type Interventional
Source Omeza, LLC
Contact Susan Shuman, RN
Phone (419) 291 2060
Email Susan.Shuman@ProMedica.org
Status Recruiting
Phase N/A
Start date September 1, 2022
Completion date December 31, 2023
View Details
See also
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