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

A Prospective, Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wound Heal; Ulcer Venous
• Intervention / Treatment: Device: InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02140
      • The Serena Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of childbearing potential must satisfy the defined contraceptive 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Area	Assessment of ulcer area (percent area reduction from baseline)	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of adverse events	12 Weeks
Time to complete wound closure	Time to complete wound closure as defined by FDA.	12 Weeks
Rate of wound closure	Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction.	12 Weeks
Reduction in pain	Assessment of the pain level linked to the wound, using the validated PEG pain scale (0-10), with a higher score indicating more severe pain and pain-related interference with life and activities.	12 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance with recommendations	Patient compliance with behavioral treatment recommendations for the healing of venous leg ulceration. Treatment recomendations defined as multilayer compression therapy (as supplied by SerenaGroup®), with weekly assessments of effectiveness of multilayer compression with patient compliance.	12 Weeks
App Usability	Assess ease of device using SUS questionnaire for WoundAlert smartphone application. To be completed by subject and provider The SUS scoring rule is as follows: (1) based on the level, each problem has a base score that ranges from 1-5, which corresponds to the range from "strongly disagree" to "strongly agree"; (2) the scores for questions 1, 3, 5, 7, and 9 are equal to the base score minus 1; the scores for questions 2, 4, 6, 8, and 10 are equal to five minus the base score; (3) the scores of the ten questions are added to obtain the total score of the questionnaire; and the questionnaire SUS score is the total score times 2.5. The SUS is represented as a percentage.	End of Study
Bacterial Burden	Reduction in bacterial burden as assessed by fluorescence imaging and polymerase chain reaction (PCR).	12 Weeks

Collaborators and Investigators

• Sponsor: ConvaTec Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: TLS-IM-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No