Venous Stasis UlcerPhase 2NCT04647240
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
A Phase 2 study testing MTX-001 (human amniotic fluid) in people with Venous Stasis Ulcer and Venous Leg Ulcer, run by Merakris Therapeutics at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stasis Ulcer, Venous Leg Ulcer
- What is being tested?
- MTX-001 (human amniotic fluid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Feb 2022to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Site 9C
Castro Valley, California, 94546
- Recruiting
Site 08
Circleville, Ohio, 43113
- Recruiting
Site 15
Humble, Texas, 77338
- Not yet recruiting
Site 16A
Los Angeles, California, 90033
- Recruiting
Site 04
New Hyde Park, New York, 11042
- Recruiting
Site 14
Opelousas, Louisiana, 70570
- Recruiting
Site 01
Salem, Virginia, 24153
- Recruiting
Site 9A
San Francisco, California, 94115
- Recruiting
Site 9B
San Francisco, California, 94117
- Not yet recruiting
Site 16B
Santa Ana, California, 92704
- Recruiting
Site 13
Tampa, Florida, 33647
- Recruiting
Site 02
Tucson, Arizona, 85715
About this study
Official title: A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
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.
Read the detailed description
DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=80). The lead-in phase of the study (Part 1) enrolled 11 eligible patients. In Part 1, patients were allocated to receive active MTX-001 once weekly or once every two weeks with standard of care. After completion of Part 1, the data was reviewed to determine the administration frequency of Study Product in Part 2 of the Study.
In Part 2, approximately 70 patients will be randomized 1:1 to receive MTX-001 or placebo (0.9% NaCl) with standard of care. Patients will be administered study treatment weekly, as needed.
Patients will receive localized subcutaneous injection of MTX-001 or placebo into and/or around the wound bed during weekly clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.
- Conditions
- Venous Stasis Ulcer, Venous Leg Ulcer
- Being tested
- MTX-001 (human amniotic fluid)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-001 (human amniotic fluid)Biological
Subcutaneous injection into and/or around wound bed weekly
| Study group | Role | What they receive |
|---|---|---|
| MTX-001 | Active comparator | MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly Receives: Biological: MTX-001 (human amniotic fluid) |
| Placebo (0.9% saline) | Placebo comparator | Matching placebo solution 0.2mL/sqcm weekly Receives: Biological: MTX-001 (human amniotic fluid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Evaluated via patient and/or Investigator reported adverse events that occur during the study
Measured: Baseline to Week 12
Preliminary efficacy
Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.
Measured: Baseline to Week 4
Secondary outcomes (6)
Total wound closure
Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits > 2 weeks
Measured: Baseline to Week 12
Ulcer size
Percent reduction of the ulcer surface area
Measured: Baseline to Week 12
Change in pain
Change in patient-reported index ulcer-related pain via the score from the Visual Analogue Scale (VAS). Scored 0-10 with higher score indicating worse pain.
Measured: Baseline to Weeks 4, 8 and 12
Change in health-related quality of life
Wound Quality of Life Questionnaire (Wound-QoL) - 17 questions with five (5) categorical response options per question (not at all, a little, moderately, quite a lot, very much)
Measured: Baseline to Week 12
Change in rate of wound closure
Change in rate of wound closure from Run-in to Baseline as compared to rate of wound closure between Baseline and Week 4.
Measured: Screening (Day -28) to Week 4.
Patient Global Impression of Change
Patient global impression of change (PGI-C), single question categorical rating scale, scored 1 to 7 with lower scores indicating better outcome.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start26 Feb 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Stasis UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merakris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647240
- Sponsor's protocol ID
- DL-VSU-201
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
- ClinicalTrials.gov ID
- NCT04647240
- Acronym / sponsor ID
- DL-VSU-201
- Conditions
- Venous Stasis Ulcer, Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Merakris TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- US Department of Veterans Affairs
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=80). The lead-in phase of the study (Part 1) enrolled 11 eligible patients. In Part 1, patients were allocated to receive active MTX-001 once weekly or once every two weeks with standard of care. After completion of Part 1, the data was reviewed to determine the administration frequency of Study Product in Part 2 of the Study.
In Part 2, approximately 70 patients will be randomized 1:1 to receive MTX-001 or placebo (0.9% NaCl) with standard of care. Patients will be administered study treatment weekly, as needed.
Patients will receive localized subcutaneous injection of MTX-001 or placebo into and/or around the wound bed during weekly clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-001 | Active comparator | Biological: MTX-001 (human amniotic fluid)MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly |
| Placebo (0.9% saline) | Placebo comparator | Biological: MTX-001 (human amniotic fluid)Matching placebo solution 0.2mL/sqcm weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-001 (human amniotic fluid)Subcutaneous injection into and/or around wound bed weekly | Biological | MTX-001, Placebo (0.9% saline) |
Primary outcome
Safety and tolerability
Time frame: Baseline to Week 12
Evaluated via patient and/or Investigator reported adverse events that occur during the study
Preliminary efficacy
Time frame: Baseline to Week 4
Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.
6 secondary outcomes
Total wound closure
Time frame: Baseline to Week 12
Ulcer size
Time frame: Baseline to Week 12
Change in pain
Time frame: Baseline to Weeks 4, 8 and 12
Change in health-related quality of life
Time frame: Baseline to Week 12
Change in rate of wound closure
Time frame: Screening (Day -28) to Week 4.
Patient Global Impression of Change
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTX-001 (human amniotic fluid) in people with Venous Stasis Ulcer and Venous Leg Ulcer, run by Merakris Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact T Che Jarrell, MBA (919-921-8105, medaffairs@merakris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.