NCT07219004

Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.

A Prospective Multi-ceter Clinical Trail. Evaluating the Efficacy of Tri-layer Amnion/Chorion/Amnion (Artacent-AC) and Standard of Care in the Treatment of Chronic Lower Extremity Diabetic Ulcers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tides Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.

Detailed description

This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period. During this trial the patient will undergo a screening period where SOC is used to see if the patient will respond and heal \> 20% of the surface area in 2 weeks. if the patient can not heal more than 20% in two week the patient then will receive a trial-layered human amnion/chorion/amnion composite graft weekly for 12 week and precent wound area reduction and complete wound healing will be recorded.

Conditions

• Lower Extremity Chronic Ulcers in Diabetics
• Diabetic Foot Ulcer (DFU)

Interventions

Type	Name	Description
OTHER	amniotic membrane	The intervention is a trial-layer human amnion/chorion/amnion composite graft

Timeline

• Start date: 2023-03-03
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2025-10-21
• Last updated: 2025-10-21

Locations

5 sites across 1 country: United States