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

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

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® Amniotic Wound Care Liquid (Dermacyte® Liquid).

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer; Venous Stasis Ulcer
• Intervention / Treatment: Biological: Dermacyte® Liquid (human amniotic fluid)

Detailed Description

DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=40). The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once weekly or once every two weeks) in Part 2 of the Study.

In Part 2, approximately 30 subjects will be randomized 1:1 to receive Dermacyte Liquid or placebo (0.9% NaCl) with standard of care. Subjects will be followed for 12 weeks.

Subjects will receive localized subcutaneous injection of Dermacyte® Liquid or placebo into and/or around the wound bed during during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chris Broderick; Phone Number: 919-921-8105; Email: info@merakris.com

Study Locations

• United States
  • Virginia
    • Salem, Virginia, United States, 24153
      • Recruiting
      • Salem VAMC
      • Contact: YVETTE SPANGLER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-75 years of age at the time of signing informed consent

• Must have full thickness ulcer

  • Ulcer surface area > 1 cm2 and < 25 cm2
  • Ulcer surface area has not increased or decreased by 25% or more within 14 days of 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.
• Received > 28 days of standard of care prior to the Baseline visit.
• Must have adequate circulation to the affected extremity as demonstrated by 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 affected leg; if subject has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, subjects must have transcutaneous (TcPO2) > 40 mmHg
• 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 within the last three years allowed
• Must have previously undergone venous hemodynamic correction via compression, surgical venous stripping, sclerotherapy, endovenous laser ablation and/or endovenous radiofrequency ablation
• Must be able to speak English

Exclusion Criteria:

• 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
• Must not have underlying osteomyelitis
• Must not be actively receiving any skin graft substitutes or regenerative therapies within 30 days prior to Baseline
• Must not have chronic musculoskeletal disorders or other diseases that limit ambulation
• Must not be receiving oral, systemically administered corticosteroids; excluded if receiving local corticosteroid injections in the lower extremities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dermacyte® Liquid (human amniotic fluid); Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly	Biological: Dermacyte® Liquid (human amniotic fluid); Subcutaneous injection into and/or around wound bed weekly
Placebo Comparator: Placebo (0.9% saline); Matching placebo solution 1.0mL to 2.0mL weekly	Biological: Dermacyte® Liquid (human amniotic fluid); Subcutaneous injection into and/or around wound bed weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Evaluated via patient and/or Investigator reported adverse events that occur during the study	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total wound closure	Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits > 2 weeks	Baseline to Week 12
Ulcer size	Percent reduction of the ulcer surface area	Baseline to Week 12
Change in pain	Change in patient-reported index ulcer-related pain via the score from the Visual Analogue Scale (VAS)	Baseline to Weeks 4, 8 and 12
Change in health-related quality of life	SF-36, DLQI, and Wound-QOL	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Merakris Therapeutics
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: November 22, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: DL-VSU-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No