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Collagen Matrix
Omeza Treatments for Diabetic Foot Ulcers
N/A
Recruiting
Led By Richard Simman, MD
Research Sponsored by Omeza, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Study Summary
This trial tests the effectiveness of 3 products to treat diabetic foot ulcers, combined with off-loading devices.
Who is the study for?
Adults over 18 with Type 1 or Type 2 diabetes and a diabetic foot ulcer (DFU) present for 1-12 months, size between 1.0 cm² and 100.0 cm², located below the ankle but not on it. Participants must understand the study, consent to procedures including offloading devices, attend weekly visits, and not be pregnant or smoking. Excluded are those with ulcers needing special treatments like negative pressure therapy or hyperbaric oxygen, suspected cancer in the ulcer area, life-threatening conditions affecting study completion, BMI>65, active cancers (except nonmelanoma skin cancer in remission for at least a year), certain allergies including fish allergy or sensitivity to standard care materials.Check my eligibility
What is being tested?
The trial is testing Omeza Lidocaine Lavage (a cleansing solution), Omeza Collagen Matrix (a wound dressing), and Omeza Skin Protectant alongside standard off-loading devices for treating DFUs. The goal is to see if these products improve healing compared to what's typically done for these ulcers.See study design
What are the potential side effects?
Potential side effects may include allergic reactions such as itching or rash due to ingredients in the products; discomfort from lidocaine use; irritation from dressings; and possible infection risk if wounds do not heal properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence in wound closure by week 12 of treatment
Percent area change after 4 weeks of treatment compared to baseline
Secondary outcome measures
Change in subject's perception of pain at baseline and weekly throughout treatment
Incidence of adverse events
Increase in physical function and ambulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Omeza combination therapy and SOC with total contact castExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Omeza, LLCLead Sponsor
6 Previous Clinical Trials
393 Total Patients Enrolled
1 Trials studying Foot Ulcer
78 Patients Enrolled for Foot Ulcer
Richard Simman, MDPrincipal InvestigatorProMedica Physician Group
1 Previous Clinical Trials
43 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an ulcer that needs to be treated with enzymatic debridement during the study.You have an ulcer that needs special treatments like negative pressure wound therapy or hyperbaric oxygen during the trial.If the doctor thinks you might have cancer, they will do a biopsy to check.You are expected to live for less than 6 months.You have a very high body mass index (BMI).The ulcer you have is not caused by diabetes.Your ulcer shows signs of infection such as tissue damage, redness, pain, and pus, or you are taking antibiotics for it.The size of the ulcer reduces by 30% or more during the 14-day screening period.You are currently smoking.You currently have any type of cancer other than nonmelanoma skin cancer, or have had cancer in the past year.The size of the study ulcer is too small (less than 2.0 cm2) or too large (greater than 100.0 cm2).You cannot walk safely using the special method required for the study.You have been diagnosed with Type 1 or Type 2 diabetes.You have a foot ulcer that goes through the skin, but it's not above the ankle.You have hepatitis.You have a foot condition that could make it hard for wounds to heal.The wound being studied is on the foot or ankle and is the biggest of multiple ulcers on the same foot with the same severity. If there are other ulcers on the same foot, they must be more than 2cm away from the main wound.The size of the study ulcer must be at least 1.0 square centimeters and no more than 100.0 square centimeters.The wound may have certain features like yellow or white slough, fibrous or scar tissue, or tissue that is not alive, but it's not required.You are currently receiving dialysis treatment.You have a condition that could slow down the healing of wounds, like severe malnutrition or certain immune system disorders.You have taken certain medications in the last 28 days that may slow down wound healing or affect it.You have a severe blood clot in a deep vein.You are allergic to lidocaine or epinephrine.You have used specific wound healing materials in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Omeza combination therapy and SOC with total contact cast
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative currently recruiting participants?
"This medical trial is open for enrolment, as confirmed by the information published on clinicaltrials.gov. Inception of this study was September 1st 2022 and its most recent update occurred June 19th 2023."
Answered by AI
What is the uppermost limit of enrollees for this experiment?
"Indeed, as detailed on clinicaltrials.gov, this trial is actively enrolling participants at the present moment. The medical experiment was initially posted in September of 2022 and has seen its last update come through June 19th 2023. A total of 25 patients are being admitted from a single site."
Answered by AI
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