Back to results

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

Primary Purpose

Venous Stasis Ulcer, Venous Leg Ulcer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dermacyte® Liquid (human amniotic fluid)

About this trial

This is an interventional treatment trial for Venous Stasis Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Salem VamcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dermacyte® Liquid (human amniotic fluid)

Placebo (0.9% saline)

Arm Description

Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly

Matching placebo solution 1.0mL to 2.0mL weekly

Outcomes

Primary Outcome Measures

Safety and tolerability

Evaluated via patient and/or Investigator reported adverse events that occur during the study

Secondary Outcome Measures

Total wound closure

Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits > 2 weeks

Ulcer size

Percent reduction of the ulcer surface area

Change in pain

Change in patient-reported index ulcer-related pain via the score from the Visual Analogue Scale (VAS)

Change in health-related quality of life

SF-36, DLQI, and Wound-QOL

Full Information

NCT ID

NCT04647240

First Posted

November 22, 2020

Last Updated

April 4, 2022

Sponsor

Merakris Therapeutics

Collaborators

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT04647240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 26, 2022 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merakris Therapeutics

Collaborators

US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Stasis Ulcer, Venous Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dermacyte® Liquid (human amniotic fluid)

Arm Type

Active Comparator

Arm Description

Dermacyte® Liquid (human amniotic fluid) solution 1.0mL to 2.0mL weekly

Arm Title

Placebo (0.9% saline)

Arm Type

Placebo Comparator

Arm Description

Matching placebo solution 1.0mL to 2.0mL weekly

Intervention Type

Biological

Intervention Name(s)

Dermacyte® Liquid (human amniotic fluid)

Intervention Description

Subcutaneous injection into and/or around wound bed weekly

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

Evaluated via patient and/or Investigator reported adverse events that occur during the study

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

Total wound closure

Description

Total ulcer closure demonstrated by skin re-epithelization without drainage or dressing requirements at two consecutive visits > 2 weeks

Time Frame

Baseline to Week 12

Title

Ulcer size

Description

Percent reduction of the ulcer surface area

Time Frame

Baseline to Week 12

Title

Change in pain

Description

Change in patient-reported index ulcer-related pain via the score from the Visual Analogue Scale (VAS)

Time Frame

Baseline to Weeks 4, 8 and 12

Title

Change in health-related quality of life

Description

SF-36, DLQI, and Wound-QOL

Time Frame

Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chris Broderick

Phone

919-921-8105

info@merakris.com

Facility Information:

Facility Name

Salem Vamc

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YVETTE SPANGLER

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs