Overview
This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
Description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus Hyalomatrix. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, are eligible to crossover to the IP arm (SOC plus Hyalomatrix). Crossover subjects will begin IP arm treatment with weekly Hyalomatrix applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
Eligibility
Inclusion Criteria:
- Male or Female, 18 years of age or older
- Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
- Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
- Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening
- Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
- Subject has a venous leg ulcer without infection or clinically visible exposed bone
- Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
- Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.
- Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1
- Index wound is free of necrotic debris prior to Hyalomatrix application
- Female subjects of childbearing potential having a negative pregnancy test prior to randomization
- Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
- Subject is able and willing to follow the protocol requirements
- Subject had signed informed consent
- If 2 or more wounds are present, the wounds must be separated by at least 2 cm
Exclusion Criteria:
- Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity
- Subject has a known life expectancy of \<1 year
- Subject is unable to comply with protocol treatment
- Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders
- Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
- Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
- Known contraindications to tissue-engineered allograft
- Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
- Subject is pregnant or breastfeeding
- Subject with history of immunosuppressant treatment (systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study
- Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization
- Venous leg ulcer with active infection
- Wound depth with visible exposed bone
- HBOT within 14 days prior to randomization
- Revascularization surgery on the index wound leg within 30 days of screening phase
- Index wound suspicious of neoplasm in the opinion of the principal investigator
