NCT02352480

Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Nuo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers

Detailed description

Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of Aurix have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the of complete wound healing in a prospective, open-label, randomized trial in which diabetic foot ulcers will be treated using Aurix to determine the time to heal at 12 weeks. Comparison will be made on a 1:1 basis of Aurix + UCC versus control subjects receiving undefined UCC.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Aurix	Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-02-02
• Last updated: 2018-01-25

Locations

20 sites across 1 country: United States