Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028386
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2023-08-26
Brief Title:
Use of AC5 Advanced Wound System in the Treatment of Diabetic Foot Ulcers
Sponsor:
Arch Therapeutics
Organization:
Arch Therapeutics
Study Overview
Official Title:
A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5 Advanced Wound System in the Treatment of Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2023-08
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:
The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with 510K FDA cleared commercially available self-assembling peptide AC5Advanced Wound System as compared to an advanced standard of care Patient outcomes will be compared at the end of the study
Detailed Description:
This study is a prospective multi-center randomized controlled study designed to collect patient outcomes data for the treatment of diabetic foot ulcers DFU All subjects will receive standard of care procedures SOC such as wound cleaning appropriate sharp debridement and appropriate offloading of the DFU eg offloading Camboot or post op shoe with offloadingwound care insole
Subjects will be randomized and receive treatments to either of the following arms
Arm 1 - Subject will receive SOC that will include AC5 Advanced Wound System as an active synthetic cellular tissue product covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance then wrapped with stretch gauze and self-adherent wrap AC5 will be applied weekly and outer dressings will be redressed if necessary using the allowed secondary dressings
Arm 2 - Subject will receive SOC that will include Fibracol Plus collagen dressing as an active dressing This will be followed with an appropriate outer dressing to maintain moisture balance then wrapped with stretch gauze and self-adherent wrap as needed Fibracol Plus will be applied 3 x a week and any outer dressings will be redressed if necessary using the allowed dressings
The study involves two phases Screening and Treatment
Subjects will be randomized and receive treatments to either of the following arms
Arm 1 - Subject will receive SOC that will include AC5 Advanced Wound System as an active synthetic cellular tissue product covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance then wrapped with stretch gauze and self-adherent wrap AC5 will be applied weekly and outer dressings will be redressed if necessary using the allowed secondary dressings
Arm 2 - Subject will receive SOC that will include Fibracol Plus collagen dressing as an active dressing This will be followed with an appropriate outer dressing to maintain moisture balance then wrapped with stretch gauze and self-adherent wrap as needed Fibracol Plus will be applied 3 x a week and any outer dressings will be redressed if necessary using the allowed dressings
The study involves two phases Screening and Treatment
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?:
False
Is an FDA AA801 Violation?:
None