Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuScience Medical Biologics, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hyalomatrix
- Standard of Care
Treatment groups
122 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov