Ignite Creation Date:
2024-05-06 @ 1:30 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04040426
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2019-07-29
Brief Title:
Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Sponsor:
Professional Education and Research Institute
Organization:
Professional Education and Research Institute
Study Overview
Official Title:
A Multi-center Randomized Controlled ClinicalTrial Evaluating a Unique Bioactive SplitThickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2022-01
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:
None
Brief Summary:
This study is a prospective multi-center randomized controlled trial designed to collect patient outcome data as well as assess performance and safety of a commercially available human split thickness skin allograft with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds
Detailed Description:
This study is a prospective multi-center Randomized Controlled Trial RCT designed to assess performance and safety and collect patient outcome data on a commercially available human split thickness skin allograft Theraskin with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds DFU The study will last thirteen weeks with a two week screening period prior to enrollment Theraskin is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271
There are two arms in the study
Arm 1 The Experimental Arm that will include SOC Therapy 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 application of human split thickness skin allograft Theraskin followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads soft roll and compression wrap DynaflexTM or equivalent
Arm 2 The Standard of Care Arm 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 calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads soft roll and compressive wrap DynaflexTM or equivalent
There are two arms in the study
Arm 1 The Experimental Arm that will include SOC Therapy 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 application of human split thickness skin allograft Theraskin followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads soft roll and compression wrap DynaflexTM or equivalent
Arm 2 The Standard of Care Arm 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 calcium alginate Fibracol dressing followed by a moisture retentive dressing and 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?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None