Actively Recruiting
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
Led by ConvaTec Inc. · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of porcine placental extracellular matrix (PPECM) combined with standard care compared to standard care alone in helping hard-to-heal venous leg ulcers close. This multicenter, randomized, observer-blinded trial focuses on adults with venous leg ulcers that have not improved significantly with prior treatment. The study aims to determine if adding PPECM can improve healing outcomes over 12 weeks. Participants are randomly assigned to one of two groups: one receiving standard care alone, which includes compression therapy, debridement, reducing bacterial burden, and maintaining moisture balance; the other receiving weekly applications of the InnovaMatrix® AC device (a porcine placental extracellular matrix product) alongside the same standard care. The treatment phase lasts 12 weeks, followed by long-term follow-up assessments at 3, 6, 9, and 12 months after wound closure or completion of treatment to evaluate durability of healing. During the study, participants attend weekly visits for treatment application and monitoring. Researchers assess outcomes such as complete ulcer closure, time to closure, percent reduction in ulcer area, and quality of life at multiple time points. Safety and efficacy are closely monitored through clinical evaluations and vascular assessments. The total participation duration includes the 12-week treatment period plus up to one year of follow-up for long-term results.
CONDITIONS
Brief 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...
- At least 21 years of age or older
- Target ulcer between 1 cm2 and 25 cm2 in size after debridement
- Ulcer present for at least 4 weeks
- Ulcer has less than 40% reduction in size over the 4 weeks prior to randomization
- Adequate blood flow in the affected limb confirmed by vascular assessment within 3 months (ABI 0.7 to ≤1.3, TBI ≥ 0.6, TCOM ≥ 40 mmHg, or biphasic PVR)
- Ulcers separated by at least 2 cm if two or more are present, with the largest ulcer chosen as target
- Willing to attend weekly study visits
- Able and willing to provide informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Signs of infection in the target ulcer requiring antibiotics or cellulitis
- Target ulcer exposing tendon or bone
- Evidence of osteomyelitis in the target ulcer
- Use of immunosuppressants or medications interfering with wound healing
- Use of topical steroids on the ulcer within one month prior to screening
- HbA1c ≥ 12% within 3 months prior to screening
- Ulcer size reduced by more than 20% in the 2 weeks before screening
- Ulcer size reduced by 20% or more during the 2-week screening phase with standard care
- History of deep vein thrombosis in lower limbs 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 trial within 30 days
- Medical or psychological conditions interfering with assessments
- Treatment with hyperbaric oxygen or cellular/acellular matrix products within 30 days
- Malnutrition score <17 on Mini Nutritional Assessment
- Allergy or sensitivity to porcine materials or collagen
- Religious or personal objection to porcine- or animal-derived materials
- Disorders posing unacceptable treatment risks
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive weekly applications of the Porcine Placental Extracellular Matrix device plus standard wound care or standard wound care alone for hard-to-heal venous leg ulcers.
Weekly visits for up to 12 weeks
Duration - Up to 12 months after wound closure or completion of treatment
Participants are monitored for the long-term durability of wound closure after completing the initial treatment phase.
Visits at 3, 6, 9, and 12 months after wound closure or treatment completion
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
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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