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

Venous Stasis Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823446
• Other study ID #: RC 03.1.1.HS1
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2009
• Last updated: June 22, 2012
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2012
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Revera Wound Care
Revalesio Part Number MDW0060
• Normal Saline
Sodium Chloride for Irrigation

Locations

Country	Name	City	State
United States	Roger Williams Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Wound edge healing rate		Weekly	Yes
Secondary	Complete Wound Closure		Weekly	No