NCT06028386

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

A Prospective Pilot Study Evaluating Wound Closure With the Application of AC5® Advanced Wound System in the Treatment of Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Arch Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (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.

Conditions

• Non-healing Wound
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	AC5® Advanced Wound System	This group will receive AC5® Advanced Wound system, a synthetic self-assembling peptide matrix to the wound and covered with non-adherent dressing followed with appropriate outer dressing to maintain moisture balance. AC5 is applied weekly and outer dressing will be redressed as necessary.
DEVICE	Fibracol Plus Collagen Dressing	This group will receive Fibracol Plus collagen dressing to the wound and covered with appropriate out dressing. Treatment will be done 3x a week.

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-04-30
• Completion: 2024-08-30
• First posted: 2023-09-08
• Last updated: 2023-09-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study