Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

Clinical Trial Description

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.

There are two standard of care arms in the study:

Arm 1: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with bioactive resorbable glass fiber dressing, MIRRAGEN™Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Arm 2: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent). ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Ulcer Foot

• NCT number: NCT03398538
• Study type: Interventional
• Source: ETS Wound Care, LLC
• Status: Completed
• Phase: N/A
• Start date: December 26, 2017
• Completion date: October 31, 2018