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

Part of paid clinical trials in North Port, Florida.

Sponsor
ConvaTec Inc.
Study ID
NCT06606210
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • InnovaMatrix® AC — DEVICE
    Weekly dressing applications

Study Details

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).

Key Dates

Start date
Sep 19, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care
    Compression, debridement, reduction of bacterial burden, and proper moisture balance.
  • Experimental: Standard of Care plus Interventional Device
    Weekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance,

Primary Outcome Measure

Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Three Rivers Wound and Hyperbaric CenterNorth PortFlorida34289
Keyur Patel, DO

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By research site
Three Rivers Wound and Hyperbaric Center· North Port, FL

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