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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00770939
Study type Interventional
Source Vivostat
Contact
Status Completed
Phase Phase 4
Start date July 2008
Completion date August 2010
View Details
See also
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