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

Phase 1

Completed

• Conditions: Venous Stasis Ulcers
• Interventions: Device: Revera Wound Care; Device: Normal Saline

• Registration Number: NCT00823446
• Lead Sponsor: Revalesio Corporation

Brief 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-15
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 18 years of age or older.

• Diagnosis of non-healing venous leg ulcer by the following criteria:

  • dependent peripheral edema, dermatitis, hyperpigmentation.
  • an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler.

• Venous Stasis Ulcer is ≥ 2 cm² in size.

• If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.

Exclusion Criteria

• Subject known to be allergic to Aquacel dressing or components.
• Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
• Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
• Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
• Involvement in another experimental drug trial within the last month.
• Clinical evidence of cellulitis or infection in or around the ulcer.
• History of non-compliance to medical regimens and is not considered reliable.
• Unable to understand the study evaluations and provide a written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revera Wound Care	Revera Wound Care	-
Normal Saline	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.	CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.

Secondary Outcome Measures

Name	Time	Method
Wound edge healing rate	Weekly
Complete Wound Closure	Weekly

Trial Locations

Locations (1)

Roger Williams Medical Center; 🇺🇸 Providence, Rhode Island, United States