Actively Recruiting
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Led by Merakris Therapeutics · Updated on 2026-04-17
80
Participants Needed
10
Research Sites
274 weeks
Total Duration
On this page
Sponsors
M
Merakris Therapeutics
Lead Sponsor
U
US Department of Veterans Affairs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily give written informed consent to participate
- Male and female patients aged 18 to 75 years for Part 1
- Male and female patients aged 18 to 90 years for Part 2
- Full thickness venous stasis ulcer with surface area between 4 cm2 and less than 25 cm2
- Ulcer surface area has not changed by 40% or more within 28 days before Baseline
- Ulcer depth at least 0.2 cm as measured by cotton tipped applicator
- Ulcer age less than 36 months prior to Baseline (Part 2 only)
- Received at least 28 days of standard wound therapy with therapeutic high-compression multilayer bandaging before Baseline
- May have had other wound treatments if clinically necessary
- Previously underwent venous hemodynamic correction via compression, surgery, sclerotherapy, laser ablation, or radiofrequency ablation
- Adequate circulation to affected leg shown by ankle-brachial index between 0.8 and 1.2 or Doppler arterial waveforms or transcutaneous oximetry over 40 mmHg if ABI is unreliable
- Venous reflux disease confirmed by Doppler ultrasound showing physiological reflux duration
- Female patients of childbearing potential must have negative pregnancy tests and follow approved contraception methods
- Male patients with partners of childbearing potential must use condoms during and 48 hours after study
- Capable of effective communication and willing to comply with study requirements
- Able to answer surveys and questionnaires in English
You will not qualify if you...
- Currently receiving topical antimicrobials or having an infected ulcer
- Ulcer with exposed bone, tendon, or ligament
- Another ulcer within 2 cm of the treated ulcer
- Pregnant, lactating, or planning pregnancy during study
- Received skin graft substitute within 30 days before Baseline
- Received corticosteroid therapy within 60 days before Baseline
- Signs of peripheral arterial disease
- Osteomyelitis or active infection interfering with study assessments
- HbA1c above 7.0% (Part 1) or 10.0% (Part 2)
- Current deep vein thrombosis (Part 2 only)
- Chronic musculoskeletal or other diseases limiting walking
- History of alcohol or drug abuse within 6 months
- Life expectancy less than 12 months
- Unstable psychiatric condition or inability to understand the study
- Currently in or recently participated in another investigational drug or device study
- Received regenerative therapy within 30 days before Baseline
- Body Mass Index over 45 (Part 2 only) or conditions preventing adequate compression therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Compass Medical Research Center
Tucson, Arizona, United States, 85715
Actively Recruiting
2
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
Actively Recruiting
3
Limb Preservation Platform, Inc.
Fresno, California, United States, 93710
Actively Recruiting
4
Center for Clinical Research Inc.
San Francisco, California, United States, 94115
Actively Recruiting
5
Center for Clinical Research, Inc.
San Francisco, California, United States, 94117
Actively Recruiting
6
ILD Research
Vista, California, United States, 92081
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Northwell Health, Inc.
New Hyde Park, New York, United States, 11042
Actively Recruiting
9
Brock Liden DPM
Circleville, Ohio, United States, 43113
Actively Recruiting
10
Salem Vamc
Salem, Virginia, United States, 24153
Actively Recruiting
Research Team
T
T Che Jarrell, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here