Is NCT04647240 recruiting in New Hyde Park, NY?

Yes, NCT04647240 is currently recruiting participants at its New Hyde Park, NY location. This venous stasis ulcers clinical trial is actively enrolling qualified participants.

How do I join the venous stasis ulcers clinical trial in New Hyde Park?

To join this clinical trial in New Hyde Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Hyde Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Venous Stasis Ulcers Clinical Trial in New Hyde Park, NY

About This Venous Stasis Ulcers Study in New Hyde Park

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 Dermacyte® Liquid (MTX-001).

Sponsor: Merakris Therapeutics

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Hyde Park?

Yes, this clinical trial (NCT04647240) has an active research site in New Hyde Park, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Venous Stasis Ulcers Treatment Options in New Hyde Park, NY

If you're searching for venous stasis ulcers treatment options in New Hyde Park, NY, this clinical trial (NCT04647240) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Hyde Park research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced venous stasis ulcers specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all venous stasis ulcers clinical trials near you to find additional studies recruiting in your area.

Venous Stasis Ulcers Clinical Trial in New Hyde Park, NY

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