Microlyte Dressing in the Management of Wounds
Microlyte
An Open-Label Prospective Pilot Study to Evaluate the Efficacy and Tolerability of Microlyte Ag Pre-Dressing in the Management of Complex Skin Wounds.
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2016
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 25, 2020
February 1, 2020
4.1 years
June 28, 2017
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure.
Wound Healing
90 days
Study Arms (4)
Venous Stasis Ulcer
ACTIVE COMPARATORVenous Stasis Ulcer
Pressure Ulcers
ACTIVE COMPARATORPressure Ulcers
Diabetic Foot Ulcers
ACTIVE COMPARATORDiabetic Foot Ulcers
Wounds from a variety of etiologies
ACTIVE COMPARATORWounds from a variety of etiologies
Interventions
Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients younger than 18 years of age
- Women who are pregnant or nursing
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mission Health System, Asheville, NClead
- Imbed Biosciencescollaborator
Study Sites (1)
Mission Health System
Asheville, North Carolina, 28801, United States
Study Officials
- STUDY CHAIR
William Shillinglaw, DO
Mission Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
October 20, 2016
Primary Completion
December 1, 2020
Study Completion
December 31, 2020
Last Updated
February 25, 2020
Record last verified: 2020-02