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

Completed

• Conditions: Ulcer Venous; Wound Heal

• Registration Number: NCT06400875
• Lead Sponsor: ConvaTec Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Study First Submitted: 2024-04-27
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound Area	12 Weeks	Assessment of ulcer area (percent area reduction from baseline)

Secondary Outcome Measures

Name	Time	Method
Rate of wound closure	12 Weeks	Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction.
Adverse Events	12 Weeks	Incidence of adverse events
Reduction in pain	12 Weeks	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.
Time to complete wound closure	12 Weeks	Time to complete wound closure as defined by FDA.

Trial Locations

Locations (1)

The Serena Group; 🇺🇸 Cambridge, Massachusetts, United States