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Extracellular Matrix

Porcine Placental Extracellular Matrix for Venous Leg Ulcers

N/A

Recruiting

Led By Thomas E. Serena, MD FACS

Research Sponsored by ConvaTec Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using porcine placental extracellular matrix along with standard treatment is more effective in healing venous leg ulcers compared to standard treatment alone.

Who is the study for?

The INNOVEN trial is for adults over 21 with venous leg ulcers that haven't improved much in the last month. The ulcer should be between 1 and 25 cm2, present for at least 4 weeks but not treated with high-level compression for more than a year. Participants need adequate blood flow to their legs as shown by specific tests.

What is being tested?

This study compares two approaches to healing venous leg ulcers: one group receives an innovative treatment using porcine placental extracellular matrix (PPECM) plus standard care, while the other group gets standard care alone. It's a randomized controlled trial, meaning participants are randomly assigned to groups.

What are the potential side effects?

While the side effects of PPECM aren't detailed here, treatments involving biological materials can sometimes cause reactions like redness or swelling at the application site, possible infection risk increase, and allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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My ulcer is between 1 cm2 and 25 cm2 after cleaning.

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My largest ulcer is at least 2 cm away from any other after cleaning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-, 6-, 9-, and 12-months after wound closure or completion of the initial 12-week treatment phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the efficacy of Porcine Placental Extracellular Matrix (PPECM) plus Standard of Care (SOC) versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks.

Secondary study objectives

Determine quality of life (QoL) for subjects receiving PPECM+SOC compared to SOC alone.

Determine the long-term durability of closure in PPECM+SOC versus SOC alone.

Determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.

+1 more

Other study objectives

Number of serious adverse events (SAE).

Number of study-ulcer infections.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care plus Interventional DeviceExperimental Treatment1 Intervention

Weekly applications of the study device in conjunction with standard of care including compression, debridement, reduction of bacterial burden, and proper moisture balance,

Group II: Standard of CareActive Control1 Intervention

Compression, debridement, reduction of bacterial burden, and proper moisture balance.

0 / 3Eligibility criteria met