[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Omeza, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100651119","ocm-treatment-with-routine-care-in-venous-leg-ulcers-compared-to-routine-care-treatment-alone-100651119",false,"NCT07754526","OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.","A Multicenter, Randomized, Controlled, Open Label Study Comparing Treatment With OCM™️ Plus Compression and Routine Care, to Compression and Routine Care Alone for Venous Leg Ulcers","1. At least 18 years old\n2. Women of Childbearing Potential (WOCBP) have a negative Point of Care (POC) urine pregnancy test\n3. As of date of randomization, the participant has demonstrated compliance with compression regimen\n4. Largest non-healing wound, if multiple wounds are present, or the single wound of interest (Index ulcer) is located between and including the knee and the ankle at or above the malleolus\n5. For participants with multiple ulcers, the largest size ulcer will be selected as the Index ulcer\n6. There is at least 2cm between the Index ulcer and other ulcers\\[WS1.1\\]\\[WS1.2\\]\n7. Index ulcer size is between 1 cm2 and 200 cm2\n8. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within (1 to 2) months of the first screening visit are acceptable:\n\n   1. Ankle-Brachial Index (ABI) ≥0.8 and ≤1.3\n   2. Toe-Brachial Indx ≥ 0.6\n   3. Transcutaneous oxygen pressure (TCOM) ≥40 mmHg\n   4. Pulse Volume Recording (PVR): biphasic or triphasic waveforms\n9. 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 blanch, edema)\n10. Willing and able to comply with study procedures, including study visits, compression and study dressing regimens (or have family member\u002Ffriend willing and able), including ability of the subject to tolerate limb compression bandage.\n11. Participant has read and signed the IRB-approved Informed Consent Form (ICF) before screening procedures are undertaken.\n12. As of date of randomization, the participant has had routine care and compression for 4 weeks and the participant's VLU has \\\u003C50% change in measurement\n13. The Index ulcer has not been treated with a topical antibiotic within the last 7 days prior to first treatment with OCM™\n\n1\\. Sensitivity to fish products or cod liver oil allergy\\[WS2.1\\]\\[SB2.2\\] 2. Study ulcer deemed by the investigator to be caused by a medical condition other than venous insufficiency 3. Study ulcer exhibits clinical signs and symptoms of infection, as evidenced by tissue necrosis, redness, pain, and\u002For purulent drainage and\u002For receiving systemic antibiotics for the treatment of such\\* 4. Study ulcer has undergone 12 or more months of continuous high-strength compression therapy over its duration.\n\n5\\. Study ulcer extends more than 50% below the malleolus 6. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 7. Simultaneous use of more than one product on the Index ulcer 8. Subjects who are unable to understand the aims and objectives of the trial or have a known history of poor adherence with medical treatment 9. The presence of any condition(s) that seriously compromises the subject's ability to complete this study 10. The subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer's etc.) 11. Subjects with a Basic Mass Index (BMI) \\>65 12. Current, uncontrolled opioid addiction per the investigator's opinion 13. Presence of any monophasic waveforms on segmental Arterial Doppler\u002FPulse Volume Recording 14. Subject is on Dialysis 15. Any active cancer other than a nonmelanoma skin cancer 16. Any previous cancer in remission for ≤1 year 17. Bone cancer or metastatic disease of the affected limb 18. Chemotherapy within the last 12 months 19. Suspicion of or confirmed malignancy by biopsy within VLU 20. Life expectancy \\\u003C6 months in the opinion of the Investigator 21. Participant has received a treatment within 28 days of screening 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, chemotherapy, revascularization surgery) to the leg, or who may receive such medications during the screening period, or who has anticipated to require such medication during the study 22. History of immunodeficiency or any illness or condition that could interfere with wound healing:\n\n* Lymphedema\n* end-stage renal disease\n* severe malnutrition\n* liver disease\n* aplastic anemia\n* Raynaud Syndrome\n* connective tissue disorder\n* acquired immune deficiency syndrome\n* HIV positive\n* sickle cell anemia\n* Untreated osteomyelitis\n* Hepatitis\n* Known acute deep venous thrombosis 23. Subject's inability to successfully tolerate compression therapy that is changed weekly 24. All females of childbearing potential who are not using a highly effective method of birth control (failure rate less that 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, practice sexual abstinence or have a vasectomized partner\n\n  * Note: an ulcer that is deemed infected at Screening might be eligible for re-screening once the infection is resolved, at the Investigator's discretion","ALL","18 Years",{"count":19,"type":20},254,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound healing; ability of the patient to return to previous function and resume normal activity, and reduction in the size of the wound. The results will be compared to patients who undergo routine care and compression without OCM™.",[26],"Venous Leg Ulcer (VLU)",[28,29,30,31],"VLU","Chronic Wound","OCM™","Multimodal Wound Matrix","NOT_YET_RECRUITING","2026-08-06",{"date":35,"type":36},"2026-08-10","ACTUAL",{"date":38,"type":20},"2026-08",{"date":40,"type":20},"2028-12",{"name":42,"class":43},"Omeza, LLC","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100605385","evaluating-the-efficacy-of-ocm-omeza-complete-matrix-in-the-treatment-of-diabetic-foot-ulcers-100605385","NCT07161830","Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers","Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy\n3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record) and being treated with continuous SOC\n4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening\n5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a diabetic foot ulcer of Wagner grade 1 or 2\n7. Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit\n8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.\n11. Index ulcer is free of necrotic debris prior to OCMTM application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectance of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to fish products or cod liver oil.\n7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 14 days prior to randomization\n11. Wound depth with visible exposed bone\n12. HBOT within 14 days prior to randomization\n13. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":53,"type":20},180,[23],"This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.",[57],"Diabetic Foot Ulcer",[59,60],"Chronic Wounds","Wound Medicine","RECRUITING","2026-07-31",{"date":64,"type":36},"2026-08-04",{"date":66,"type":36},"2025-12-04",{"date":68,"type":20},"2027-03-30",{"name":42,"class":43},10,""]