Porcine Placental Matrix for Non-Healing Leg Ulcers
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
Recruiting
N/AInterventional Study
Wound HealVenous Leg Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
ConvaTec Inc. · Industry
Who this trial is looking for
This trial is looking for adults with venous leg ulcers that have not healed. Participants will receive either a special treatment plus standard care or just the standard care to see which works better.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 21 years old.
I have a leg ulcer that has been present for at least 4 weeks.
My ulcer is between 1 cm2 and 25 cm2 in size after cleaning.
I have not seen improvement in my ulcer in the last 4 weeks.
I can attend weekly study visits.
You may not be able to join if
I expect to live less than 6 months.
My ulcer shows signs of infection.
My ulcer exposes tendon or bone.
I have had a deep vein thrombosis in the last 90 days.
I have taken topical steroids for my ulcer in the last month.
I am pregnant or planning to become pregnant in the next 6 months.
I cannot tolerate therapeutic compression.
I have a sensitivity to porcine materials.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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 a…
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.
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