1. Trial Details/Purpose

Venous leg ulcers (VLUs) affect 1-2% of U.S. adults, particularly those over 65. An estimated 500,000 to 2 million people suffer from VLUs, often caused by chronic venous insufficiency, obesity, and previous injuries. VLUs are highly recurrent, with 60-80% of patients experiencing recurrence within 5 years. ​This clinical trial, called INNOVEN, is a study designed to test whether a new treatment, InnovaMatrix® AC, which is made from porcine placental extracellular matrix (PPECM), can help heal hard-to-treat venous leg ulcers (VLUs) when used alongside standard wound care.Venous leg ulcers are chronic open wounds that occur due to poor circulation in the legs. They are slow to heal and can significantly impact a person's quality of life. This study aims to determine if the PPECM material can speed up healing and improve patient outcomes compared to standard care alone.  PPECM could offer a new, effective treatment to speed up healing and improve patient quality of life.

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​2. Inclusion Criteria

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• Age: 21 years or older.

• Ulcer Size: Wounds must be between 1 cm² and 25 cm² in size.

• Ulcer Duration: The wound must have been present for at least 4 weeks.

• Wound Healing Status: The ulcer must have shown less than 40% improvement over the past 4 weeks.

• Adequate Blood Flow: Blood circulation to the affected leg must be confirmed through tests such as Ankle-Brachial Index (ABI) or Transcutaneous Oxygen Measurement (TCOM).

• Multiple Wounds: If a participant has multiple ulcers, the largest qualifying ulcer will be selected.

• Commitment: Participants must agree to attend weekly study visits for treatment and monitoring

 

3. Exclusion Criteria

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• Life Expectancy: Expected to live less than 6 months.

• Active Infection: The wound shows signs of severe infection, requiring antibiotics.

• Bone Exposure: The ulcer exposes bone or tendon.

• Osteomyelitis: Bone infection related to the ulcer.

• Medication Conflicts: Taking immunosuppressants, chemotherapy, or biologic drugs that could interfere with healing.

• Recent Steroid Use: Applied topical steroids to the wound within the last month.

• Diabetes Control: Severely uncontrolled diabetes (HbA1c ≥ 12%).

• Wound Healing Rate: If the wound shrinks by more than 20% within the first two weeks of screening.

• History of Blood Clots: Deep Vein Thrombosis (DVT) in the last 90 days.

• Compression Therapy: Unable to tolerate medical-grade compression bandages (30-40mmHg).

• Pregnancy: Women who are pregnant or planning pregnancy.

• Kidney Disease: End-stage renal disease requiring dialysis.

• Other Clinical Trials: Participated in another experimental treatment trial in the last 30 days.

• Nutritional Status: Malnutrition based on the Mini Nutritional Assessment.

• Religious or Personal Objections: Those who do not want to use porcine (pig-derived) products.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location

 

     Northridge ​​​​​​