Actively Recruiting
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
Led by ConvaTec Inc. · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be at least 21 years of age or older.
- Target ulcer must have a surface area between 1 cm2 and 25 cm2 measured after debridement.
- Ulcer must have been present for at least 4 weeks and not have received more than 52 weeks of high-level compression prior to screening.
- Ulcer must show less than 40% reduction in size over the 4 weeks before randomization.
- Affected limb must have adequate blood flow confirmed by vascular tests within 3 months before screening (ABI 0.7 to ≤1.3, TBI ≥0.6, TCOM ≥40 mmHg, or biphasic PVR).
- If more than one ulcer is present, ulcers must be at least 2 cm apart post-debridement; largest ulcer meeting criteria will be selected.
- Must agree to attend weekly study visits as required.
- Must be willing and able to participate in the informed consent process.
You will not qualify if you...
- Life expectancy less than 6 months.
- Target ulcer with signs of infection requiring antibiotics or surrounding cellulitis.
- Ulcer exposing tendon or bone.
- Evidence of osteomyelitis complicating the ulcer.
- Receiving immunosuppressants (e.g., high-dose corticosteroids) or chemotherapy or medications interfering with wound healing.
- Use of topical steroids on the ulcer within 1 month prior to screening.
- Glycated hemoglobin (HbA1c) ≥12% within 3 months before screening.
- Ulcer size reduced by more than 20% in the 2 weeks before screening.
- Ulcer size decreased by 20% or more during the 2-week screening phase with standard care.
- History of lower extremity deep vein thrombosis within 90 days.
- Unable to tolerate therapeutic compression (30-40 mmHg).
- Women who are pregnant or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Participation in another investigational treatment trial within 30 days.
- Medical or psychological conditions that may interfere with study assessments.
- Treatment with hyperbaric oxygen therapy or similar products within 30 days before screening.
- Malnutrition indicator score less than 17 on Mini Nutritional Assessment.
- Known allergy or sensitivity to porcine materials or collagen.
- Religious or personal objections to porcine or animal-derived materials.
- Disorders posing unacceptable risk of treatment complications.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Three Rivers Wound and Hyperbaric Center
North Port, Florida, United States, 34289
Actively Recruiting
Research Team
A
Andrea Picchietti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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