Wound Heal
Conditions
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).
Interventions
DEVICEWound 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
Imbed Biosciences
Mission Health System, Asheville, NC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. | 90 days | Wound Healing |
Countries
United States
Contacts
Primary ContactLorinda Baker
Backup ContactAshley Boone, BS
Outcome results
None listed