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NCT05291169
Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers
NA trial testing Omeza® OCM™ in Venous Leg Ulcer in 54 participants. Completed in 1 March 2024.
30 November 2023
Quick facts
| Lead sponsor | Omeza, LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 11 April 2022 |
| Primary completion | 30 November 2023 |
| Estimated completion | 1 March 2024 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Omeza® OCM™
Conditions studied
- Venous Leg Ulcer — all drugs for Venous Leg Ulcer →
Sponsor
Omeza, LLC
Who can join
18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Randomized, Multicenter, Open Label Study Comparing Omeza Combination Therapy with Standard of Care to Standard of Care alone for Chronic Venous Leg Ulcers over the course of 4 weeks
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Novel Comprehensive Therapeutic Approach to the Challenges of Chronic Wounds: A Brief Review and Clinical Experience Report.
Bettle G, Bell DP, Bakewell SJ. · · 2024 · cited 13× · PMID 38104037 · DOI 10.1007/s12325-023-02742-4
Verify or expand the search:
- PubMed search for NCT05291169
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Venous Leg Ulcer
Currently open trials in the same condition.
- NCT07255937 — PMCF Study of Debridement Pad · NA · recruiting
- NCT07046767 — CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations · NA · recruiting
- NCT07211243 — Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers · NA · recruiting
- NCT07061613 — Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers · NA · recruiting
- NCT06544564 — Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population · NA · recruiting
Other Omeza, LLC trials
Trials by the same sponsor.
- NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
- NCT05417425 — Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers · Phase 1 · completed
- NCT05921292 — Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies · EARLY_PHASE1 · completed
- NCT04512274 — Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin · NA · completed
- NCT04510675 — Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05291169 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Omeza, LLC
- Last refreshed: 6 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05291169.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing