NCT00823446

Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Revalesio Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

Detailed description

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment. This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate. The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care. This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.

Conditions

• Venous Stasis Ulcers

Interventions

Type	Name	Description
DEVICE	Revera Wound Care	Revalesio Part Number MDW0060
DEVICE	Normal Saline	Sodium Chloride for Irrigation

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-01-15
• Last updated: 2012-06-26

Locations

1 site across 1 country: United States