MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Venous Stasis Ulcer, Venous Leg Ulcer

In brief

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.

Key facts

Study ID

NCT04647240

Run by

Merakris Therapeutics

People needed

80

Starts

2022-02-26

Expected to finish

2027-05-31

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Received ≥ 28 days of standard, conventional wound therapy with a therapeutic high-compression (≥40 mmHg), multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, patients may have received other wound treatments as needed (e.g., surgical debridement, pressure offloading, negative pressure and/or hyperbaric oxygen therapy).
• Patient must have previously undergone venous hemodynamic correction via therapeutic compression (≥40 mmHg), surgical venous stripping, sclerotherapy, endovenous laser ablation, and/or endovenous radiofrequency ablation.
• Patient must have adequate circulation to the affected extremity as demonstrated by the most recently measured ankle-brachial index (ABI) greater than or equal to 0.8 and less than or equal to 1.2 or triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg (as applicable). If patient has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, patients must have transcutaneous oximetry (TcPO2) > 40 mmHg.
• Patient must have VSU caused by underlying venous reflux disease with physiological reflux lasting greater than or equal to 500 milliseconds for superficial veins OR 1.0 seconds for deep veins, as confirmed by most recent Doppler ultrasound venous mapping from Baseline; historical results/confirmation within the previous three years allowed.
• Patients who agree to follow the specified precautions to avoid pregnancy as follows:
• Patients who are female of childbearing potential include any female patient who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). For female patients of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating Study Product. Female patients of childbearing potential must follow 1 of the following approaches:
• Practice actual abstinence from intercourse
• Have a partner with a vasectomy
• Have an intrauterine device
• Must use 2 different forms of highly effective contraception for the duration of the study, and for at least 48 hours after discontinuing study drug. Medically acceptable forms of effective contraception include approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm).
• Male patients with a partner of childbearing potential must use a condom during intercourse for the duration of the study, and for 48 hours after discontinuing study drug.
• Patients who, in the opinion of the Investigator, are capable of communicating effectively with study personnel and are considered reliable, willing, and likely to be cooperative with protocol requirements and attend all required study visits.
• Patients who have the capability to answer surveys and questionnaires written in English.

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.
• Patients with an active infection or condition that would interfere with interpretation of study assessments.
• Patients with an HbA1c > 7.0% (Part 1 only) or HbA1c > 10.0% (Part 2 only), as collected at Screening or in the previous 90 days prior to Screening.
• Patients with current deep vein thrombosis (DVT) (Part 2 only)
• Patients with chronic musculoskeletal disorder or any other disease that would limit ambulation.
• Patients with a history of alcohol abuse or illicit drug abuse within 6 months of Baseline which, in the Investigator's opinion, would make the patient inappropriate for enrollment in a clinical study.
• Patients with any other concomitant disease with life expectancy of <12 months from Baseline
• Patients with an unstable psychiatric condition or those not capable of understanding the objectives, nature, or consequences of the study, or who have any condition which, in the Investigator's opinion, would constitute an unacceptable risk to the patient's safety.
• Patients who are currently receiving an investigational drug, have an investigational device in place, or who have participated in an investigational drug or device study within 90 days prior to Baseline. Participation in an observational study within 90 days prior to Baseline does not disqualify a patient from enrolling.
• Patients who have received another regenerative therapy within 30 days prior to Baseline.
• Patients with a Body Mass Index (BMI) > 45 (Part 2 only) or other clinical symptoms (e.g. edema) that do not allow for adequate therapeutic compression.

Where it is running

• Site 02 — Tucson, Arizona, United States (enrolling)
• Site 9C — Castro Valley, California, United States (enrolling)
• Site 03 — Fresno, California, United States (enrolling)
• Site 9A — San Francisco, California, United States (enrolling)
• Site 9B — San Francisco, California, United States (enrolling)
• Site 12 — Vista, California, United States (enrolling)
• Site 13 — Tampa, Florida, United States (enrolling)
• Site 14 — Opelousas, Louisiana, United States (enrolling)
• Site 04 — New Hyde Park, New York, United States (enrolling)
• Site 08 — Circleville, Ohio, United States (enrolling)
• Site 01 — Salem, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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