A Clinical Study to Evaluate the Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies
A Clinical Study to Evaluate the Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies
The goal of this clinical trial is to evaluate the use of Omeza combination therapy with Standard of Care. The main question it aims to answer is:
- Can Omeza combination therapy with Standard of Care enable chronic wounds to begin a healing trajectory in a 4-week period?
Patients will be treated with:
The goal of this clinical trial is to demonstrate that the Omeza combination therapy with Standard of Care supports chronic wounds to move from chronicity to a healing trajectory. The trial is targeting those wounds that have failed therapy prior to trial enrollment and are chronic by definition of no change in area size after 2 weeks of standard of care treatment. The inclusion and exclusion criteria applied to this chronic wound clinical trial is broadened with the intention to include all patients and outliers that would not qualify for controlled trials.
Inclusion Criteria:
Additional Inclusion Criteria (for Subjects with Wounds/Ulcers in Lower Extremities):
The affected limb must have adequate perfusion confirmed by vascular assessment. Any one of the following methods performed within 1 or 2 months of the first screening visit are acceptable:
Confirmation of venous disease by non-invasive venous studies with either Doppler confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclerosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g., cancer on ulcers ≥ 6 months
Have a venous ulcer between the knee and ankle, at or above the malleolus
Subject understands and is willing to participate in the clinical study visits including compression if needed for minimum 14 days (compression dressing changed once weekly) prior to study start, participate in the informed consent process, and can comply with weekly visits and the follow-up regimen
If more than one chronic wound/ulcer is present on the same leg, they must be greater than 2 cm apart and only the larger chronic wound/ulcer will be included in the study (i.e., targeted lesion)
Additional Inclusion Criteria (for Subjects with Diabetic Foot Ulcer):
Exclusion Criteria:
Targeted chronic wounds/ulcers exhibit clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and/or purulent drainage and/or receiving systemic antibiotics for the treatment of such*
Targeted chronic wound/ulcer treated with a topical antibiotic within the last 7 days prior to first treatment with Omeza products.
a. NOTE: washout of topical antibiotics and antibacterial treatments (eg. Silver, manuka honey, iodine, etc) is at least 7 days before first treatment with Omeza products.
Targeted chronic wound/ulcer has been treated with any placental derived products, engineered material (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, PuraPly AM or Matristem) within the last 30 days.
Targeted chronic wound/ulcer requires enzymatic debridement during the study
Targeted chronic wound/ulcer decreases in area by 30% or more during the 14 days screening/run-in period.
Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment.
Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer's, etc.)
Presence of any condition(s) that seriously compromises the subject's ability to complete this study.
Subjects with a BMI>65
Subject has any history of fish allergy or a known sensitivity to any of the SoC materials which contact the skin
Presence of any monophasic waveforms on segmental Arterial Doppler/Pulse Volume Recording
Subject is on dialysis
Any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 1 year: bone cancer of metastatic disease of the affected limb, or has had chemotherapy within the last 12 months
Suspicion of malignancy within chronic wounds/ulcers: A biopsy must be performed for any wound that has been present for > 6 months and has not previously been biopsied. A biopsy should be performed regardless of duration of wound If a clinical suspicion of malignancy exists in the opinion of the Investigator.
Life expectancy < 6 months
Subject has received within 28 days of screening a treatment which is known to interfere with or affect the rate and quality of wound healing (e.g., thrombolysis, systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy at wound site, chemotherapy) or who may receive such medications during the screening period or who has anticipated to require such medications during the course of the study at the discretion of the treatment PI.
Untreated osteomyelitis
Acute deep venous thrombosis
Allergy to lidocaine and/or epinephrine
Subject's inability to successfully tolerate compression therapy that is changed weekly
All females of childbearing potential who are not using a highly effective method of birth control (failure rate less than 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner.
The use of the following treatments are prohibited within 30 days prior to randomized treatment and throughout the study:
Additional Exclusion Criteria (for Subjects with Wounds/Ulcers in Lower Extremities):
The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 1 or 2 months of the first screening visit are exclusionary:
Suspicion of malignancy within VLU
Acute deep venous thrombosis
Study target chronic wound/ulcer extends more than 50% below the malleolus.
Additional Exclusion Criteria (for Subjects with Diabetic Foot Ulcer):
Target wound deemed by the investigator to be caused by a medical condition other than diabetes or subject has wounds secondary to a disease other than diabetes (e.g. vasculitis, neoplasms, or hematological disorders)
The affected limb of the diabetic subject must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 1 or 2 months of the first screening visit are exclusionary:
The subject is unable to safely ambulate with the use of a study required offloading method
Subject has unstable Charcot foot or Charcot with bone exposed that could inhibit wound healing
Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the subject will not be enrolled)