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

Launched by CONVATEC INC. · Sep 18, 2024

Keywords

ClinConnect Summary

The INNOVEN clinical trial is studying the use of a special tissue product called porcine placental extracellular matrix (PPECM) combined with standard wound care to see if it helps heal stubborn venous leg ulcers (VLUs) better than standard care alone. This trial is currently recruiting participants who are at least 21 years old and have a specific type of leg ulcer that has not improved for at least four weeks. To qualify, the ulcer must be between 1 and 25 square centimeters in size and have shown little to no healing in that time. Participants need to be able to attend weekly study visits and agree to the informed consent process.

If you join the trial, you will receive either the PPECM treatment plus standard care or just the standard care alone, which typically includes things like compression bandages and proper wound cleaning. It's important to note that certain health conditions, such as infections, severe diabetes, or recent surgeries, might prevent someone from participating. Overall, this study aims to understand if adding the PPECM treatment can significantly help heal difficult-to-treat leg ulcers, potentially making a positive difference in many patients' lives.

Gender

ALL

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.