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Microlyte Dressing in the Management of Wounds

NCT03204851 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-02-25

No results posted yet for this study

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).

Conditions

  • Wound Heal

Interventions

DEVICE

Wound Healing

Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.

Sponsors & Collaborators

  • Imbed Biosciences

    collaborator INDUSTRY

  • Mission Health System, Asheville, NC

    lead OTHER

Principal Investigators

  • William Shillinglaw, DO · Mission Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2020-12-01
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204851 on ClinicalTrials.gov