Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05417425|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2022
Last Update Posted : September 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single arm to evaluate efficacy in chronic, non-healing wounds.|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study Using Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers|
|Estimated Study Start Date :||September 2022|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Omeza combination therapy and SOC with total contact cast
Omeza's products were developed to utilize the benefits of essential omega fatty acids to reduce chronic inflammation and disrupt biofilm colonization commonly found in chronic wounds. The Omeza combination treatment under investigation in this study includes two over the counter (OTC) drugs, Omeza® Lidocaine Lavage and Omeza® Skin Protectant, and a 510(K) medical device, Omeza® Collagen Matrix.
In combination with standard of care and total contact cast, the products will be applied on a weekly basis. There will be a 14-day screening period to assess chronicity from standard of care alone. At that time treatment will be applied weekly for 4 weeks. Further treatment will be at the discretion of the PI to continue for 8 more weeks or until wound closure.
Combination Product: Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
The three omeza products were designed to be used in combination for the treatment of chronic wounds
- Percent area change after 4 weeks of treatment compared to baseline [ Time Frame: 6 weeks ]After a 2 week screening phase with standard of care and total contact casting, the wound will be measured and assessed by Tissue Analytics platform. At each treatment visit the change in the wound size and healing status will be assessed. After 4 weeks of treatment the change in wound size will be compared to baseline measurement from treatment visit 1 and the percent area reduction (PAR) recorded.
- Incidence in wound closure by week 12 of treatment [ Time Frame: 14 weeks ]Treatment will continue and measurements recorded by Tissue Analytics platform until wound closure or up to 12 weeks of treatment.
- Incidence of adverse events [ Time Frame: 14 weeks ]Safety of the products used in combination will be assessed by the PI and assesses throughout treatment for adverse events or reactions to the products.
- Change in subject's perception of pain at baseline and weekly throughout treatment [ Time Frame: 14 weeks ]Subjects will be required to assess ulcer pain at baseline and at each treatment visit by a questionnaire assessing pain on a numerical scale
- Increase in physical function and ambulation [ Time Frame: 14 weeks ]Subjects will be asked to complete a questionnaire to assess physical function and ambulation status at baseline and at each treatment visit.