Using porcine placental matrix to improve healing of venous leg ulcers

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

This study is testing if adding a special treatment made from pig placenta to regular care can help heal stubborn leg ulcers that haven't improved with standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: ConvaTec Inc. (industry)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (North Port, Florida)
• Trial ID: NCT06606210 on ClinicalTrials.gov

What this trial studies

INNOVEN is a multi-center randomized controlled clinical trial designed to assess the effectiveness of porcine placental extracellular matrix (PPECM) combined with standard care compared to standard care alone in treating non-healing venous leg ulcers. Participants will be randomly assigned to receive either the PPECM treatment or standard care, with their progress monitored over time. The trial aims to determine if the addition of PPECM can enhance wound closure rates in patients with chronic ulcers that have not responded to conventional treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with non-healing venous leg ulcers that have not improved over the past month.

Not a fit: Patients with ulcers that have shown improvement or those with ulcers outside the specified size and duration criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing rates for patients suffering from chronic venous leg ulcers.

How similar studies have performed: Other studies have explored the use of extracellular matrices in wound healing, showing promising results, but this specific approach with porcine placental matrix is relatively novel.

Eligibility criteria

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.
6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
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.

Exclusion Criteria:

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).
9. 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.
10. The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.
11. The potential subject is unable to tolerate therapeutic compression (30-40mmHg).
12. Women who are pregnant or considering becoming pregnant within the next 6 months.
13. The potential subject has end stage renal disease requiring dialysis.
14. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.
15. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
16. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
17. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
18. Potential subjects with a sensitivity or allergy to porcine materials or collagen.
19. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials.
20. A subject with a disorder that would create unacceptable risk of treatment complications.

Where this trial is running

North Port, Florida

• Three Rivers Wound and Hyperbaric Center — North Port, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Thomas E. Serena, MD FACS — SerenaGroup, Inc.
• Study coordinator: Andrea Picchietti

Conditions: Wound Heal, Venous Leg Ulcer