Using Dermacyte® Liquid to treat non-healing venous stasis ulcers

A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

This study is testing if Dermacyte® Liquid can help people with stubborn venous stasis ulcers heal better than a placebo over 12 weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Merakris Therapeutics (industry)
• Locations: 10 sites (Tucson, Arizona and 9 other locations)
• Trial ID: NCT04647240 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Dermacyte® Liquid in patients with non-infected venous stasis ulcers that have not improved after at least four weeks of standard wound therapy. The study is divided into two parts: the first part will determine the optimal frequency of Dermacyte administration, while the second part will compare the active treatment to a placebo over a 12-week period. Participants will receive localized injections of the treatment or placebo and will be monitored for changes in wound size and healing progress at specified intervals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with full thickness venous stasis ulcers that have not responded to conventional therapy.

Not a fit: Patients with infected ulcers or those whose ulcers have been present for more than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic venous stasis ulcers.

How similar studies have performed: While this approach is innovative, similar studies using amniotic fluid for wound healing have shown promising results.

Eligibility criteria

Inclusion Criteria:

* 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
  * 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Tucson, Arizona and 9 other locations

• Compass Medical Research Center — Tucson, Arizona, United States (RECRUITING)
• Center for Clinical Research, Inc. — Castro Valley, California, United States (RECRUITING)
• Limb Preservation Platform, Inc. — Fresno, California, United States (RECRUITING)
• Center for Clinical Research Inc. — San Francisco, California, United States (RECRUITING)
• Center for Clinical Research, Inc. — San Francisco, California, United States (RECRUITING)
• ILD Research — Vista, California, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• Northwell Health, Inc. — New Hyde Park, New York, United States (RECRUITING)
• Brock Liden DPM — Circleville, Ohio, United States (RECRUITING)
• Salem Vamc — Salem, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: T Che Jarrell, MBA

Conditions: Venous Stasis Ulcer, Venous Leg Ulcer