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NCT05506215: DFUs
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
NA trial testing SynPath Acellular Dermal Matrix plus Off-loading Device in Diabetic Foot in 25 participants. Terminated before completion.
26 February 2024
Quick facts
| Lead sponsor | PolyNovo Biomaterials Pty Ltd. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 10 July 2022 |
| Primary completion | 26 February 2024 |
| Estimated completion | 26 February 2024 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- SynPath Acellular Dermal Matrix plus Off-loading Device
- Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
Conditions studied
- Diabetic Foot — all drugs for Diabetic Foot →
- Chronic Foot Ulcer — all drugs for Chronic Foot Ulcer →
- Wound Healing — all drugs for Wound Healing →
- Foot Ulcer — all drugs for Foot Ulcer →
Sponsor
PolyNovo Biomaterials Pty Ltd.
Who can join
18 and older, any sex, with Diabetic Foot or Chronic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05506215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot
Currently open trials in the same condition.
- NCT06487780 — Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers · NA · recruiting
- NCT06674980 — Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DF · NA · recruiting
- NCT06760416 — Online Diabetic Foot Support Program- Care Kit · NA · active not recruiting
- NCT06552910 — Analyzing Anesthetic Techniques in Diabetic Foot Amputation · recruiting
- NCT06526936 — The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior · NA · recruiting
Other PolyNovo Biomaterials Pty Ltd. trials
Trials by the same sponsor.
- NCT02905435 — Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries · 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 NCT05506215 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PolyNovo Biomaterials Pty Ltd.
- Last refreshed: 5 March 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/NCT05506215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing