INNOVEN: InnovaMatrix® AC for Venous Leg Ulcers

This study, called INNOVEN, is looking at how well a product called InnovaMatrix® AC works for hard-to-heal venous leg ulcers (open sores on the leg caused by poor blood flow). You would receive either InnovaMatrix® AC plus the usual care, or just the usual care alone. Researchers want to see if adding InnovaMatrix® AC helps these ulcers close completely within 12 weeks. To join, you must be at least 21 years old and have a leg ulcer between 1 and 25 square centimeters that has been present for at least 4 weeks. The current status of this study is unclear, so it's not known if they are actively looking for participants.

Study design
This is a randomized controlled trial, meaning participants are assigned by chance to one of two groups. It aims to enroll 120 people and is observer-blinded, so some study staff won't know which treatment you are receiving.
What's involved
You would receive weekly dressing applications of InnovaMatrix® AC if you are in that group. The primary goal is measured at 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06606210

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

Recruiting
NAAges 21+InterventionalTreatment
ConvaTec Inc.
~120 participants
Updated 2025-08-22 on ClinicalTrials.gov
What's tested:InnovaMatrix® AC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 12 weeks
Wound Heal
Venous Leg Ulcer
1 sites across 1 states
Florida1
  • Thomas E. Serena, MD FACS · PRINCIPAL_INVESTIGATOR · SerenaGroup, Inc.

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  • 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.12 weeks

    The percentage of target ulcers achieving complete wound closure defined as complete epithelialisation of the wound surface.