MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerakris Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Ulcer surface area ≥ 4 cm2 and < 25 cm2
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MTX-001 (human amniotic fluid)
Biological/VaccineSubcutaneous injection into and/or around wound bed weekly
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: MTX-001Active comparator 1 intervention
Group B: Placebo (0.9% saline)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability
Evaluated via patient and/or Investigator reported adverse events that occur during the study
Time frame
Baseline to Week 122
Preliminary efficacy
Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.
Time frame
Baseline to Week 4Secondary outcomes
1
Total wound closure
Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits \> 2 weeks
Time frame
Baseline to Week 122
Ulcer size
Percent reduction of the ulcer surface area
Time frame
Baseline to Week 123
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.
Time frame
Baseline to Weeks 4, 8 and 124
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)
Time frame
Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Merakris Therapeutics
Lead sponsor
US Department of Veterans Affairs
Collaborator
Source ClinicalTrials.gov