At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Borate-based Bioactive Glass Advanced Wound Matrix and Standard of Care Versus Standard of Care Alone
In Brief
A clinical study evaluating Mirragen Advanced Wound Matrix and Fibracol for Diabetic Foot Ulcer and 2 related conditions. Completed, enrolled 148 participants across 15 sites.
Detailed Summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
Study Details
Timeline
Interventions
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Fibracol - application of Fibracol to wound site along with standard of care treatment.