Clinical Trial: Provant Therapy of Venous Stasis Ulcer Trial

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Provant Therapy of Venous Stasis Ulcer Trial

Brief 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.

Detailed Summary:
Sponsor: Southern California Institute for Research and Education

Current Primary Outcome: Rates of wound closure (measured as change in surface area - mm2/day) [ Time Frame: during and after 12 weeks of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of wounds achieving complete healing [ Time Frame: afer 12 weeks of therapy ]

Original Secondary Outcome: Same as current

Information By: Southern California Institute for Research and Education

Dates:
Date Received: January 13, 2010
Date Started: November 2009
Date Completion: November 2011
Last Updated: July 19, 2011
Last Verified: July 2011