Microlyte Dressing in the Management of Wounds (Microlyte)
Primary Purpose
Wound Heal
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound Healing
Sponsored by
About this trial
This is an interventional treatment trial for Wound Heal
Eligibility Criteria
Inclusion Criteria:
- Men and women ≥18 years of age, inclusive
- Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
- Patient must be competent to consent for self
Exclusion Criteria:
- Patients younger than 18 years of age
- Women who are pregnant or nursing
- Prisoners
Sites / Locations
- Mission Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Venous Stasis Ulcer
Pressure Ulcers
Diabetic Foot Ulcers
Wounds from a variety of etiologies
Arm Description
Venous Stasis Ulcer
Pressure Ulcers
Diabetic Foot Ulcers
Wounds from a variety of etiologies
Outcomes
Primary Outcome Measures
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
Wound Healing
Secondary Outcome Measures
Full Information
NCT ID
NCT03204851
First Posted
June 28, 2017
Last Updated
February 24, 2020
Sponsor
Mission Health System, Asheville, NC
Collaborators
Imbed Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT03204851
Brief Title
Microlyte Dressing in the Management of Wounds
Acronym
Microlyte
Official Title
An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mission Health System, Asheville, NC
Collaborators
Imbed Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer [DFU] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venous Stasis Ulcer
Arm Type
Active Comparator
Arm Description
Venous Stasis Ulcer
Arm Title
Pressure Ulcers
Arm Type
Active Comparator
Arm Description
Pressure Ulcers
Arm Title
Diabetic Foot Ulcers
Arm Type
Active Comparator
Arm Description
Diabetic Foot Ulcers
Arm Title
Wounds from a variety of etiologies
Arm Type
Active Comparator
Arm Description
Wounds from a variety of etiologies
Intervention Type
Device
Intervention Name(s)
Wound Healing
Intervention Description
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.
Primary Outcome Measure Information:
Title
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
Description
Wound Healing
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women ≥18 years of age, inclusive
Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
Patient must be competent to consent for self
Exclusion Criteria:
Patients younger than 18 years of age
Women who are pregnant or nursing
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorinda Baker
Phone
828-257-4744
Email
lorinda.baker@hcahealthcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Boone, BS
Phone
828-213-3961
Email
Ashley.boone@hcahealthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Shillinglaw, DO
Organizational Affiliation
Mission Health System
Official's Role
Study Chair
Facility Information:
Facility Name
Mission Health System
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Boone, BS
Phone
828-213-3961
Email
ashley.boone@msj.org
First Name & Middle Initial & Last Name & Degree
Nicole Gunn, MA
Phone
828-213-7055
Email
nicole.gunn@msj.org
12. IPD Sharing Statement
Learn more about this trial
Microlyte Dressing in the Management of Wounds
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