NCT00770939

Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers

A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vivostat · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diabetic foot ulcers are a challenge to health care professionals because there are only few effective topical therapeutic interventions. Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in conjunction with extensive surgical debridement. Autologues platelet releasate which contains platelet derived growth factor appears to be more effective than standard therapy in case studies. This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot ulcers to identify responders and to enable sample size calculation for a subsequent pivotal trial.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Vivostat PRF	Ulcer will be treated week 1,2,3,4,5 and 6 with Vivostat PRF

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2008-10-10
• Last updated: 2011-10-12

Locations

5 sites across 3 countries: Denmark, Germany, Sweden