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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 aims to see if Omeza combo therapy with current care can help chronic wounds heal in 4 weeks.
Who is the study for?
Adults with chronic wounds or ulcers present for at least two months, measuring 2-100 cm² without exposed tendon, muscle, or bone. Participants must have adequate blood flow in the affected limb and not be pregnant. They should understand trial procedures and agree to follow them, including dressing regimens and possibly wearing compression bandages.Check my eligibility
What is being tested?
The trial is testing Omeza combination therapy alongside Standard of Care treatments to see if it can kickstart healing within four weeks for chronic cutaneous wounds/ulcers. Patients will receive both Omeza products and standard wound care during the study.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to skin treatments such as local irritation, rash, itching or allergic reactions. Since Standard of Care varies per case, associated side effects would depend on those specific treatments.
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
Change in Wound Area
Chronicity of Wound Healing
Wound Closure
+1 moreSecondary outcome measures
Drainage/Exudate and Infection
Enhanced Activities in Daily Living
Improvement in Quality of Life
+3 moreSide effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Omeza Products Used in CombinationExperimental Treatment1 Intervention
Subjects in this single-arm study will have the targeted wound/ulcer treated with Omeza combination therapy which includes the use of lidocaine lavage (2mL vial), cod liver oil skin protectant (2mL vial), and collagen matrix wound dressing (2ml vial). Patients will be treated weekly for four weeks. Treatment may be continued weekly for an additional 8 weeks with participant and investigator agreement.
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Who is running the clinical trial?
Omeza, LLCLead Sponsor
6 Previous Clinical Trials
318 Total Patients Enrolled
Desmond Bell, DPMStudy DirectorOmeza Holdings, Inc
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diabetic foot ulcer.I have a deep foot ulcer below my ankle.If I have more than one wound on the same leg, they are over 2 cm apart and only the larger one will be studied.My foot's bone infection is confirmed by a recent x-ray.My wound shows signs of infection like redness, pain, or pus.I haven't used heat lamps, UV lights, whirlpool baths, hyperbaric oxygen, or insulin on my skin in the last 30 days.I am over 18 and not pregnant.I have a recent deep vein clot.My chronic wound has shrunk by 30% or more in the last 14 days.I have used a topical antibiotic on my chronic wound in the last week.I have a long-lasting wound that hasn't been biopsied but might be cancerous.I cannot tolerate weekly compression therapy.I am currently receiving dialysis.My wound has not been treated with placental products or engineered materials in the last 30 days.Blood flow in my affected limb is confirmed to be good.I have a leg ulcer between my knee and ankle.My chronic wound is between 2 and 100 cm2 and does not show tendon, muscle, or bone.My BMI is over 65.I have a bone infection that hasn't been treated.My affected limb has good blood flow.I cannot walk safely even with help.I haven't taken any medication in the last 28 days that could affect wound healing.I have been diagnosed with venous disease and have had a biopsy to rule out other skin conditions.My chronic wound needs special cleaning treatment.I have a severe foot condition that could prevent wounds from healing.My wound is not due to diabetes but another medical condition.I have been diagnosed with Type 1 or Type 2 diabetes.I understand the trial's goals and have a good history of following medical advice.I have no active cancers except for nonmelanoma skin cancer, and any past cancers have been in remission for over a year.I do not have wounds or ulcers on my lower extremities.I am of childbearing age and not using effective birth control.I do not have a diabetic foot ulcer.I might have cancer within my venous leg ulcer.My chronic wound is mostly below my ankle.My chronic wound has been present for at least 2 months.I am willing and able to follow the study's procedures and wear any required dressings or compression bandages.My largest foot or ankle ulcer will be the focus of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Omeza Products Used in Combination
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.
Is enrollment in this experiment still available to volunteers?
"Data from clinicaltrials.gov confirms that the trial, which was initially posted on July 11th 2022, is in need of participants. It has been updated as recently as June 19th 2023."
Answered by AI
Has the FDA cleared Omeza Products for use in conjunction with other medications?
"Omeza Products Used in Combination's safety is estimated to be a 1, as this Phase I trial has only limited evidence that suggests its efficacy and safety."
Answered by AI
How many participants are being recruited for this experiment?
"Affirmative. Information found on clinicaltrials.gov shows that this scientific trial, which was first announced on July 11th 2022, is actively recruiting volunteers. 100 individuals are sought from a single medical facility."
Answered by AI
What are the primary aims of this research endeavor?
"Over the course of 4 weeks, this clinical trial will gauge Wound Area Changes as its primary endpoint. Secondary objectives are focused on Reported Pain Perception (utilizing a 10 cm Visual Analogue Scale to capture changes in pain), Enhanced Activities in Daily Living (captured by an instrumental ADL scale such as the Barthel Index) and Drainage/Exudate and Infection assessment made at each visit when changing dressings."
Answered by AI
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