Clinical trial NCT06400875: Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcer Venous
Wound Heal
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound Area
timeFrame: 12 Weeks
Secondary outcomes:
measure: Time to complete wound closure
timeFrame: 12 Weeks
measure: Rate of wound closure
timeFrame: 12 Weeks
measure: Adverse Events
timeFrame: 12 Weeks
measure: Reduction in pain
timeFrame: 12 Weeks
Other outcomes:
measure: Patient compliance with recommendations
timeFrame: 12 Weeks
measure: App Usability
timeFrame: End of Study
measure: Bacterial Burden
timeFrame: 12 Weeks
Locations:
city: Cambridge
country: United States
facility: The Serena Group
state: Massachusetts
Study officials:
References: