NCT03398538

Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: ETS Wound Care, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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).

Conditions

• Diabetic Foot Ulcer
• Ulcer Foot
• Diabetic Foot

Interventions

Type	Name	Description
OTHER	Offloading	Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
OTHER	Additional (outer) Dressing Application	Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
OTHER	Mirragen Wound Matrix Dressing	Application of Mirragen to wound site along with standard of care treatment
OTHER	Fibracol Wound Dressing	Application of Fibracol Alginate along with standard of care treatment

Timeline

• Start date: 2017-12-26
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2018-01-12
• Last updated: 2022-08-03

Locations

5 sites across 1 country: United States