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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.

Terminated NA Last updated 22 September 2021
What this trial tests

NA trial testing PuraPly® Antimicrobial Wound Matrix in Chronic Pressure Ulcers in 40 participants. Terminated before completion.

Timeline
1 May 2018
Primary endpoint
15 September 2021
15 September 2021

Quick facts

Lead sponsorOrganogenesis
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment40
Start date1 May 2018
Primary completion15 September 2021
Estimated completion15 September 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

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.

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Other Organogenesis trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing