NCT01816672

Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.

A Multi-Center, Prospective, Clinical Trial Comparing the Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner 1 and 2 Diabetic Foot Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Cytomedix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care

Detailed description

Autologel is a platelet-rich plasma gel used in the treatment of no-healing chronic wounds. Prospective observational studies of the effectiveness of Autologel have demonstrated promising results in regard to the healing of diabetic foot ulcers including severe Wagner grade 3 and 4 ulcers. The aim of the current trial is to compare the efficacy, measured as wound healing in a single-blind (assessor) randomized controlled trial, of usual and customary care with and without Autologel in treating Wagner 1 and 2 diabetic foot ulcers.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	AutoloGel	Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter
OTHER	Usual and Customary Care	Standard of care treatment twice weekly for 2 weeks then weekly

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-03-22
• Last updated: 2016-10-21

Locations

1 site across 1 country: United States