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NCT05417425
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
Phase 1 trial testing Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant in Diabetic Foot Ulcers in 25 participants. Completed in 31 December 2023.
31 October 2023
Quick facts
| Lead sponsor | Omeza, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 September 2022 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Omeza collagen matrix, Omeza lidocaine lavage, Omeza skin protectant
Conditions studied
- Diabetic Foot Ulcers — all drugs for Diabetic Foot Ulcers →
Sponsor
Omeza, LLC
Who can join
18 and older, any sex, with Diabetic Foot Ulcers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to evaluate the efficacy of OCM™ used in combination with off-loading devices for the treatment of diabetic foot ulcers.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Innovative Functional Biomaterials as Therapeutic Wound Dressings for Chronic Diabetic Foot Ulcers.
Da Silva J, Leal EC, Carvalho E, Silva EA. · · 2023 · cited 27× · PMID 37373045 · DOI 10.3390/ijms24129900 -
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 NCT05417425
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot Ulcers
Currently open trials in the same condition.
- NCT06189638 — Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers · Phase 2 · active not 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
- NCT05921292 — Omeza Combination Therapy for the Management and Treatment of Chronic Cutaneous Wounds/Ulcers of Multiple Etiologies · EARLY_PHASE1 · completed
- NCT05291169 — Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers · NA · 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 NCT05417425 (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: 21 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/NCT05417425.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing