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

NCT04647240 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DL-VSU-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Venous Stasis Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability

  Evaluated via patient and/or Investigator reported adverse events that occur during the study

  Baseline to Week 12

• Preliminary efficacy

  Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.

  Baseline to Week 4

Secondary Outcomes (6)

• Total wound closure

  Baseline to Week 12

• Ulcer size

  Baseline to Week 12

• Change in pain

  Baseline to Weeks 4, 8 and 12

• Change in health-related quality of life

  Baseline to Week 12

• Change in rate of wound closure

  Screening (Day -28) to Week 4.

Study Arms (2)

MTX-001

ACTIVE COMPARATOR

MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly

Biological: MTX-001 (human amniotic fluid)

Placebo (0.9% saline)

PLACEBO COMPARATOR

Matching placebo solution 0.2mL/sqcm weekly

Biological: MTX-001 (human amniotic fluid)

Interventions

MTX-001 (human amniotic fluid) BIOLOGICAL

Subcutaneous injection into and/or around wound bed weekly

MTX-001; Placebo (0.9% saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Merakris Therapeutics: lead
• US Department of Veterans Affairs: collaborator

Study Sites (10)

Compass Medical Research Center

Tucson, Arizona, 85715, United States

RECRUITING

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

RECRUITING

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

RECRUITING

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

RECRUITING

Center for Clinical Research, Inc.

San Francisco, California, 94117, United States

RECRUITING

ILD Research

Vista, California, 92081, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Northwell Health, Inc.

New Hyde Park, New York, 11042, United States

RECRUITING

Brock Liden DPM

Circleville, Ohio, 43113, United States

RECRUITING

Salem Vamc

Salem, Virginia, 24153, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

T Che Jarrell, MBA

CONTACT

919-921-8105; medaffairs@merakris.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 30, 2020
• Study Start: February 26, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)