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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT00823446
First received: January 13, 2009
Last updated: June 22, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Wound edge healing rate [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Complete Wound Closure [ Time Frame: Weekly ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823446

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

No publications provided

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT00823446     History of Changes
Other Study ID Numbers: RC 03.1.1.HS1
Study First Received: January 13, 2009
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014