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/A Interventional Study
Wound Heal Venous 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.

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About This Trial

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…
Contacts

Andrea Picchietti

727-247-5234

andrea.picchietti@convatec.com

CONTACT