NCT01050023

Provant Therapy of Venous Stasis Ulcer Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Southern California Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Stasis Ulcers

Interventions

Type	Name	Description
DEVICE	Provant Device (Wound Therapy System)	Twice daily application of the active Provant device to the wound for twelve (12) weeks.
DEVICE	Provant Device - Inactive	Twice daily application of the inactive Provant device to the wound for twelve (12) weeks.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-01-15
• Last updated: 2011-07-20

Locations

2 sites across 1 country: United States