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INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone

NCT06606210 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-22

No results posted yet for this study

Summary

INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs).

Conditions

  • Wound Heal
  • Venous Leg Ulcer

Interventions

DEVICE

InnovaMatrix® AC

Weekly dressing applications

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas E. Serena, MD FACS · SerenaGroup, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2025-12-31
Completion
2026-04-30
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 NCT06606210 on ClinicalTrials.gov