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

NCT06606210 | Recruiting FDA Device

• 1 other identifier: WC-24-454
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

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

  12 weeks

Secondary Outcomes (6)

• Determine the time to closure for ulcers achieving complete closure over 12-weeks for PPECM+SOC versus SOC alone.

  12 weeks

• Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.

  12 weeks

• Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.

  Day 0, 4 weeks, 8 weeks, and 12 weeks

• Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.

  Day 0, 4 weeks, 8 weeks, and 12 weeks

• Determine the long-term durability of closure in PPECM+SOC versus SOC alone.

  3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase

Other Outcomes (2)

• Number of serious adverse events (SAE).

  12 month

• Number of study-ulcer infections.

  12 month

Study Arms (2)

Standard of Care

NO INTERVENTION

Compression, debridement, reduction of bacterial burden, and proper moisture balance.

Standard of Care plus Interventional Device

EXPERIMENTAL

Weekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance,

Device: InnovaMatrix® AC

Interventions

InnovaMatrix® AC DEVICE

Weekly dressing applications

Also known as: Porcine Derived Extracellular Matrix

Standard of Care plus Interventional Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 21 years of age or older.
• 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.
• 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.
• 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.
• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject is known to have a life expectancy of \< 6 months.
• 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.
• The target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis complicating the target ulcer.
• 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).
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• 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).
• The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
• The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.
• The potential subject is unable to tolerate therapeutic compression (30-40mmHg).
• Women who are pregnant or considering becoming pregnant within the next 6 months.
• The potential subject has end stage renal disease requiring dialysis.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

Three Rivers Wound and Hyperbaric Center

North Port, Florida, 34289, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas E. Serena, MD FACS

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Picchietti

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 20, 2024
• Study Start: September 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)