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NCT03502824
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
NA trial testing PuraPly® Antimicrobial Wound Matrix in Chronic Pressure Ulcers in 40 participants. Terminated before completion.
15 September 2021
Quick facts
| Lead sponsor | Organogenesis |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 1 May 2018 |
| Primary completion | 15 September 2021 |
| Estimated completion | 15 September 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- PuraPly® Antimicrobial Wound Matrix
- SOC for Pressure Ulcers
Conditions studied
- Chronic Pressure Ulcers — all drugs for Chronic Pressure Ulcers →
Sponsor
Organogenesis — full company profile →
Who can join
Adults 18 to 99, any sex, with Chronic Pressure Ulcers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03502824
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT03502824 (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 Organogenesis
- Last refreshed: 22 September 2021
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/NCT03502824.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing