RecruitingVenous Stasis UlcerVenous Leg Ulcer
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Merakris Therapeutics
You may qualify if…
- ✓ 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
- ✓ Patients having a full thickness ulcer that meets the following criteria:
- ✓ Ulcer surface area ≥ 4 cm2 and \< 25 cm2
- ✓ Ulcer surface area hasn't increased or decreased by 40% or more, as assessed within 28 days prior to Baseline
- ✓ Ulcer depth ≥ 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound.
- ✓ Ulcer age \< 36 months (1095 days) prior to Baseline (for Part 2 only)
You may not qualify if…
- ✕ 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.
- ✕ Patients actively receiving or received any skin graft substitute within 30 days prior to Baseline.
- ✕ Patients receiving oral, systemically administered, or lower extremity injectable corticosteroid therapy within 60 days prior to Baseline.
- ✕ Patients with angiographic or clinical signs of peripheral arterial disease (PAD)
- ✕ Patients with underlying osteomyelitis.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04647240 · last updated 2026-06-22