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Collagen Matrix
Omeza® Collagen Matrix for Venous Leg Ulcer
N/A
Recruiting
Led By Thomas Serena, MD, FACS
Research Sponsored by SerenaGroup, Inc.
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 12 weeks
Awards & highlights
Study Summary
This trial is testing whether a combination therapy including Omeza can heal chronic venous leg ulcers better than the standard of care alone over 4 weeks.
Eligible Conditions
- Venous Leg Ulcer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate change in ulcer size at week 4 (percent area reduction) compared to baseline
To evaluate the impact on chronicity of wound healing by Omeza Combination Therapy and Standard of Care (multilayer compression) at week 4 compared to Standard of Care
To evaluate the safety profile of the Omeza Combination Therapy for chronic venous leg ulcers
Secondary outcome measures
Change in the subjects' Quality of Life (QoL) a. week to week using a numerical scale b. reported pain perception c. assessment of drainage d. enhanced activities in daily living
Other outcome measures
Change in bacterial fluorescence using the MolecuLight device at baseline and weekly.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Omeza Combination Therapy + SOCExperimental Treatment1 Intervention
The Omeza Combination Therapy under investigation includes two Over the Counter (OTC) drugs, Omeza®Lidocaine Lavage for periwound preparation and pain control, and Omeza® Skin Protectant to be applied to the skin from knee to ankle for increased perfusion. Omeza® Collagen Matrix is an FDA cleared 510(K) medical device which is applied directly to the wound bed. The combination treatment is applied on a weekly basis, followed by compression management
Group II: SOCActive Control1 Intervention
Cleaning and debriding the Study ulcers and compression management on a weekly basis.
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Who is running the clinical trial?
SerenaGroup, Inc.Lead Sponsor
21 Previous Clinical Trials
1,726 Total Patients Enrolled
Omeza, LLCLead Sponsor
6 Previous Clinical Trials
308 Total Patients Enrolled
Thomas Serena, MD, FACSPrincipal InvestigatorSerenaGroup, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of being allergic to fish or any materials that touch your skin during the study.The size of the ulcer being studied should be between 4 and 100 square centimeters.You have a history of illnesses or conditions that can weaken your immune system or hinder the healing of wounds. These include conditions like severe malnutrition, liver disease, or certain blood disorders.You have an ulcer that needs special treatments like negative pressure wound therapy or hyperbaric oxygen during the trial.You are not expected to live for more than 6 months.You have an ulcer that needs to be treated with special enzymes during the study.You have an ulcer that goes more than halfway down your ankle bone.If you have an ulcer, it must be treated with a special cream during the initial tests.You are allergic to lidocaine or epinephrine.The ulcers being studied may have characteristics like yellow/white slough or scar tissue, but it's not necessary for every ulcer to have these features.You are currently a smoker.You are unable to tolerate having compression therapy applied and changed every week.If you have a wound that has been there for more than 6 months and hasn't been checked by a doctor, they will need to do a biopsy. If the doctor suspects that the wound might be cancerous, they will also do a biopsy, no matter how long the wound has been there.You have an untreated bone infection called osteomyelitis.The size of your ulcer decreases by at least 30% during the 14-day screening period.You have used certain types of treatments for your wound in the past month, such as tissue engineered material or scaffold materials.You have an ulcer that the doctor believes is caused by something other than poor blood flow in your veins.If you have an infected ulcer, you may be able to participate in the study after the infection is treated. The decision will be made by the person in charge of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Omeza Combination Therapy + SOC
- Group 2: SOC
Awards:
This trial has 1 awards, including:- 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.
What is the limit on how many people can take part in this experiment?
"To complete the trial, 110 qualified patients must be recruited. This can happen at Serena Group in Monroeville (Pennsylvania) and ACMH Wound Clinic in Kittanning (Texas)."
Answered by AI
Is this research actively looking for participants?
"The trial, which was issued on April 11th 2022, is open for applications and has been recently modified according to information found in clinicaltrials.gov - the latest update being June 7th of this year."
Answered by AI
How many sites are managing this trial's operations?
"At this time, the trial is operating at 5 facilities in Monroeville, Kittanning, Austin and two other sites. To ease travel demands on those involved, we suggest selecting a site closest to you if participating."
Answered by AI
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