Microlyte Dressing in the Management of Wounds

Last updated: February 24, 2020
Sponsor: Mission Health System, Asheville, NC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03204851
16-08-1608
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women ≥18 years of age, inclusive

  • Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to bereferred to Clinical Investigators at Mission's Wound Care and Bariatric Center

  • Patient must be competent to consent for self

Exclusion

Exclusion Criteria:

  • Patients younger than 18 years of age

  • Women who are pregnant or nursing

  • Prisoners

Study Design

Total Participants: 100
Study Start date:
October 20, 2016
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Mission Health System

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

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