Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403605
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Sponsor:
ETS Wound Care LLC
Organization:
ETS Wound Care LLC
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BGWM
Brief Summary:
This study is a prospective multi-center randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC 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 subjects 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 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 the study is offloading of the DFU CAM boots or total contact casting TCC if the subjects 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 follwed by a padded 3-layer dressing comprised of 4x4 gauze pads soft roll and compressive wrap DynaflexTM or equivalent
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 subjects 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 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 the study is offloading of the DFU CAM boots or total contact casting TCC if the subjects 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 follwed by a padded 3-layer dressing comprised of 4x4 gauze pads soft roll and compressive wrap DynaflexTM or equivalent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None