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New treatment option for Venous Stasis Ulcer
Official title MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
ClinicalTrials.gov ID: NCT04647240
What this study is testing
What is MTX-001 (human amniotic fluid)?
MTX-001 (human amniotic fluid) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for venous stasis ulcer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Males and female patients aged 18 to 90 years inclusive at Screening (date the patient provides written informed consent to participate in study) for...
- Patients having a full thickness ulcer that meets the following criteria:
- Ulcer surface area ≥ 4 cm2 and \< 25 cm2
You likely can't join if
- Patient must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment according to The...
- 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.
See the full eligibility criteria
Who can 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients who have the capability to answer surveys and questionnaires written in English.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Castro Valley, California, United States
- Fresno, California, United States
- San Francisco, California, United States
- Vista, California, United States
- Tampa, Florida, United States
- Opelousas, Louisiana, United States
- New Hyde Park, New York, United States
- Circleville, Ohio, United States
- Salem, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Castro Valley, California, United States; Fresno, California, United States; San Francisco, California, United States; Vista, California, United States; Tampa, Florida, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.