Use of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

Status Recruiting

Clinical Trial 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, AC5®Advanced Wound System, as compared to an advanced standard of care. Patient outcomes will be compared at the end of the study.

Clinical Trial 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 (e.g., offloading Camboot or post op shoe with offloading/wound 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06028386
Study type	Interventional
Source	Arch Therapeutics
Contact	Evelyn Quintin
Phone	6174312308
Email	equintin@archtherapeutics.com
Status	Recruiting
Phase	N/A
Start date	August 15, 2023
Completion date	August 30, 2024

View Details

See also
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