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RECRUITINGNA

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

An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care Versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers

NCT06606210•ConvaTec Inc.

View on ClinicalTrials.gov

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).

Detailed Description

An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must be at least 21 years of age or older.
•2. At randomization subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
•3. The target ulcer must have been present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
•4. No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to randomization.
•5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
•1. ABI between 0.7 and ≤ 1.3;
•2. TBI ≥ 0.6;
•3. TCOM ≥ 40 mmHg;
•4. PVR: biphasic.

Exclusion Criteria

•7. The potential subject must agree to attend the weekly study visits required by the protocol.
•8. The potential subject must be willing and able to participate in the informed consent process.
•1. The potential subject is known to have a life expectancy of \< 6 months.
•2. The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
•3. The target ulcer exposes tendon or bone.
•4. There is evidence of osteomyelitis complicating the target ulcer.
•5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics).
•6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
•7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
•8. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Digital planimetry is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
+12 more criteria

Locations (1)

Three Rivers Wound and Hyperbaric Center

North Port, Florida, United States

Key Dates

Start Date

September 19, 2024

Primary Completion Date

December 1, 2025

Completion Date

April 1, 2026

Last Updated

August 22, 2025

Enrollment

120

ESTIMATED participants

Conditions

Wound HealVenous Leg Ulcer

Interventions

InnovaMatrix® AC

DEVICE

Contacts

Andrea Picchietti

CONTACT

727-247-5234 andrea.picchietti@convatec.com

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

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Wound Healing

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RECRUITINGNA

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

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Wound HealingPalatal Wound+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Exploring if Patients Can Safely and Easily Swab Their Own Surgical Wounds at Home

An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds

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