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

NCT ID: NCT06400875

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

2. Patients who are willing and able to attend all follow-up visits.

3. Index ulcer characteristics:

1. Ulcer present for ≥ 30 days prior to (Day 0).

2. Index ulcer is above the malleolus.

3. Ulcer greater than or equal to 2cm2 and less than or equal to 20cm2 at the time of enrollment.

4. 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.

5. The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping.

6. The subject is medically stable, in the opinion of the investigator.

Potential subjects meeting any of the following criteria will be excluded from enrollment

1. Index Ulcer Assessment:

1. Penetrates down to muscle, tendon, or bone.

2. Presence of another venous leg ulcer within 2 cm of the index ulcer

3. Index ulcer determined to be due to a condition other than venous insufficiency.

4. Exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.

5. Known or suspected local skin malignancy to the index diabetic ulcer.

6. Wound duration > one year without intermittent closure.

2. Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:

1. In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer

2. In the last 7 days - Hyperbaric oxygen (HBO) therapy

3. In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or subject is anticipated to require such medications during the course of the study

4. In the last 30 days - study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem Wound Matrix )

5. In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg

3. Subject criteria that will make subject ineligible for enrollment:

1. Known hypersensitivity to porcine based products.

2. Known osteomyelitis or active cellulitis requiring antimicrobial therapy at wound site.

3. End stage renal disease requiring dialysis.

4. Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV

5. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.

6. Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

7. Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited.

8. Subjects currently receiving radiation therapy or chemotherapy.

9. Any pathology that would limit the blood supply and compromise healing or non-revascularizable surgical sites

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Serena Group

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

TLS-IM-002

Identifier Type: -

Identifier Source: org_study_id