Provant Therapy of Venous Stasis Ulcer Trial

Venous Stasis Ulcers Clinical Trial

Official title: Provant Therapy of Venous Stasis Ulcer Trial

Status Active, not recruiting

Clinical Trial Summary

This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers

• NCT number: NCT01050023
• Study type: Interventional
• Source: Southern California Institute for Research and Education
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2009
• Completion date: November 2011