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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hyalomatrix
DeviceHyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.
Standard of Care
Other interventionWound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Standard of CareActive comparator 1 intervention
Group B: Hyalomatrix + Standard of CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Wound Closure
The primary endpoint will be the percentage of target wounds that achieve complete wound closure within 12 weeks.
Time frame
1-12 weeksSecondary outcomes
1
Weekly Percentage Area Reduction
The percentage reduction in wound area from 1-12 weeks will be measured weekly using digital photographic planimetry and physical examination.
Time frame
1-12 weeks2
Pain Assessment
Change in pain associated with the target wound will be assessed using the Numeric Pain Rating Scale throughout the study. Numeric Rating on a scale of 0-10. o is No pain and 10 is the worst possible pain.
Time frame
1-14 weeksOther outcomes
1
Time to Closure
Average number of grafts/weeks used to achieve wound closure
Time frame
1-12 weeks2
Follow-Up Closure
Number of wounds that re-opened during the 2-week follow-up
Time frame
2 weeks3
Adverse Events and Serious Adverse Events
The number and nature of adverse events (AEs) and serious adverse events (SAEs) occurring during the study will be tracked and reported.
Time frame
1-12 weeksSponsors and contacts
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Source ClinicalTrials.gov