Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU

NCT06400875 | Active Not Recruiting DMC FDA Device

• 1 other identifier: TLS-IM-002
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.

Conditions

Ulcer Venous; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Wound Area

  Assessment of ulcer area (percent area reduction from baseline)

  12 Weeks

Secondary Outcomes (4)

• Time to complete wound closure

  12 Weeks

• Rate of wound closure

  12 Weeks

• Adverse Events

  12 Weeks

• Reduction in pain

  12 Weeks

Other Outcomes (3)

• Patient compliance with recommendations

  12 Weeks

• App Usability

  End of Study

• Bacterial Burden

  12 Weeks

Interventions

InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM) DEVICE

weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will consist of SerenaGroup® advanced wound care centers or affiliates that will enroll a minimum of 30 subjects.

You may not qualify if:

• Patients who are willing and able to attend all follow-up visits.
• Index ulcer characteristics:
• Ulcer present for ≥ 30 days prior to (Day 0).
• Index ulcer is above the malleolus.
• Ulcer greater than or equal to 2cm2 and less than or equal to 20cm2 at the time of enrollment.
• Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days:
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or
• ABIs with results of ≥ 0.7 and ≤ 1.2, Or
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI \>1.2 TBI (Toe Brachial Index) \> 0.5.
• Patient able to ambulate at home or in the clinic with or without mobility aids.
• The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping.
• The subject is medically stable, in the opinion of the investigator.
• Potential subjects meeting any of the following criteria will be excluded from enrollment
• Index Ulcer Assessment:
• Penetrates down to muscle, tendon, or bone.

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (1)

The Serena Group

Cambridge, Massachusetts, 02140, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 6, 2024
• Study Start: July 10, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)