MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerakris Therapeutics
About this trial
DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.
Eligibility criteria
Qualifiers
Patients who voluntarily give written informed consent to participate in study
Males and female patients aged 18 to 75 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 1 only
Males and female patients aged 18 to 90 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 2 only
Ulcer surface area ≥ 4 cm2 and < 25 cm2
Disqualifiers
Patient must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment according to The International Wound Infection Institute (IWII) criteria (e.g. odor, color, visual appearance) rather than culture.
Ulcer must not have exposed bone, tendon, or ligament.
Patient must not have another ulcer within 2 cm from the ulcer receiving investigational treatment.
Female patients who are pregnant, lactating, or planning to become pregnant during the study.
Trial design
Treatments tested in this trial
- MTX-001 (human amniotic fluid)
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Merakris Therapeutics
Lead sponsor
US Department of Veterans Affairs
Collaborator
Source ClinicalTrials.gov