RECRUITING

Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Two Part, Randomized Study of Dermacyte® Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers

Quick Facts

Study Start:2022-02-26

Study Completion:2025-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04647240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects who voluntary give written informed consent to participate in study * Males and female subjects aged 18 to 75 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 1 only * Males and female subjects aged 18 to 80 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 2 only * Subjects must have a full thickness ulcer that meets the following criteria: * Ulcer surface area \> 1 cm2 and \< 25 cm2 * Ulcer surface area hasn't increased or decreased by 25% or more, as assessed within 14 days or more 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 \< 12 months (365 days) prior to Baseline (for Part 2 only) * Received \> 28 days of standard, conventional wound therapy with a high-compression, multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, subjects may have received other wound treatments as needed (e.g., surgical debridement, pressure off-loading, negative pressure and/or hyperbaric oxygen therapy). * Subjects must have previously undergone venous hemodynamic correction via compression, surgical venous stripping, sclerotherapy, endovenous laser ablation, and/or endovenous radiofrequency ablation. * Subjects 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 subject has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, subjects must have transcutaneous oximetry (TcPO2) \> 40 mmHg. * Subjects must have VSU caused by underlying venous reflux disease with physiological reflux lasting greater than 500 milliseconds for superficial veins and 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. * Subjects who agree to follow the specified precautions to avoid pregnancy as follows: * 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 subjects 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. * Subjects 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. * Subjects who have the capability to answer surveys and questionnaires written in English.	* Subject must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment (e.g. odor, color, visual appearance) rather than culture. * Ulcer must not have exposed bone, tendon, or ligament. * Subject must not have another ulcer within 3 cm from the ulcer receiving investigational treatment. * Female subjects who are pregnant, lactating, or planning to become pregnant during the study. * Subjects actively receiving or received a skin graft substitutes within 30 days prior to Baseline. * Subjects receiving oral, systemically administered, or lower extremity

Inclusion Criteria

Exclusion Criteria

* Subjects who voluntary give written informed consent to participate in study
* Males and female subjects aged 18 to 75 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 1 only
* Males and female subjects aged 18 to 80 years inclusive at Screening (date the subject provides written informed consent to participate in study) for Part 2 only
* Subjects must have a full thickness ulcer that meets the following criteria:
* Ulcer surface area \> 1 cm2 and \< 25 cm2
* Ulcer surface area hasn't increased or decreased by 25% or more, as assessed within 14 days or more 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 \< 12 months (365 days) prior to Baseline (for Part 2 only)
* Received \> 28 days of standard, conventional wound therapy with a high-compression, multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, subjects may have received other wound treatments as needed (e.g., surgical debridement, pressure off-loading, negative pressure and/or hyperbaric oxygen therapy).
* Subjects must have previously undergone venous hemodynamic correction via compression, surgical venous stripping, sclerotherapy, endovenous laser ablation, and/or endovenous radiofrequency ablation.
* Subjects 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 subject has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, subjects must have transcutaneous oximetry (TcPO2) \> 40 mmHg.
* Subjects must have VSU caused by underlying venous reflux disease with physiological reflux lasting greater than 500 milliseconds for superficial veins and 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.
* Subjects who agree to follow the specified precautions to avoid pregnancy as follows:
* 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 subjects 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.
* Subjects 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.
* Subjects who have the capability to answer surveys and questionnaires written in English.

* Subject must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment (e.g. odor, color, visual appearance) rather than culture.
* Ulcer must not have exposed bone, tendon, or ligament.
* Subject must not have another ulcer within 3 cm from the ulcer receiving investigational treatment.
* Female subjects who are pregnant, lactating, or planning to become pregnant during the study.
* Subjects actively receiving or received a skin graft substitutes within 30 days prior to Baseline.
* Subjects receiving oral, systemically administered, or lower extremity

Contacts and Locations

Study Contact

T Che Jarrell, MBA

CONTACT

919-921-8105

medaffairs@merakris.com

Study Locations (Sites)

Compass Medical Research Center

Tucson, Arizona, 85715

United States

Center for Clinical Research, Inc.

Castro Valley, California, 94546

United States

Limb Preservation Platform, Inc.

Fresno, California, 93710

United States

Center for Clinical Research Inc.

San Francisco, California, 94115

United States

Center for Clinical Research, Inc.

San Francisco, California, 94117

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Northwell Health, Inc.

New Hyde Park, New York, 11042

United States

Brock Liden DPM

Circleville, Ohio, 43113

United States

Salem Vamc

Salem, Virginia, 24153

United States

Collaborators and Investigators

Sponsor: Merakris Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-26

Study Completion Date2025-10-15

Study Record Updates

Study Start Date2022-02-26

Study Completion Date2025-10-15

Terms related to this study

Additional Relevant MeSH Terms

Venous Stasis Ulcer
Venous Leg Ulcer