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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823446
First Posted: January 15, 2009
Last Update Posted: June 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Revalesio Corporation
  Purpose
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.

Condition Intervention Phase
Venous Stasis Ulcers Device: Revera Wound Care Device: Normal Saline Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet. [ Time Frame: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur. ]

Secondary Outcome Measures:
  • Wound edge healing rate [ Time Frame: Weekly ]
  • Complete Wound Closure [ Time Frame: Weekly ]

Enrollment: 13
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Revera Wound Care Device: Revera Wound Care
Revalesio Part Number MDW0060
Placebo Comparator: Normal Saline Device: Normal Saline
Sodium Chloride for Irrigation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823446


Locations
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Revalesio Corporation
  More Information

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT00823446     History of Changes
Other Study ID Numbers: RC 03.1.1.HS1
First Submitted: January 13, 2009
First Posted: January 15, 2009
Last Update Posted: June 26, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis