NCT03204851: Microlyte

Microlyte Dressing in the Management of Wounds

Status unknown NA Last updated 25 February 2020

What this trial tests

NA trial testing Wound Healing in Wound Heal in 100 participants. Status unknown.

Timeline

20 October 2016

Primary endpoint
1 December 2020

31 December 2020

Quick facts

Lead sponsor	Mission Health System, Asheville, NC
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	20 October 2016
Primary completion	1 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Wound Healing

Conditions studied

• Wound Heal — all drugs for Wound Heal →

Sponsor

Mission Health System, Asheville, NC

Who can join

18 and older, any sex, with Wound Heal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.