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Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU

NCT06400875 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2025-05-29

No results posted yet for this study

Summary

The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.

Conditions

  • Ulcer Venous
  • Wound Heal

Interventions

DEVICE

InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)

weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400875 on ClinicalTrials.gov