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Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

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ClinicalTrials.gov Identifier: NCT00727701
Recruitment Status : Terminated (Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.)
First Posted : August 4, 2008
Last Update Posted : June 26, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

Condition or disease Intervention/treatment Phase
Varicose Ulcer Behavioral: Aftercare summary Phase 1

Detailed Description:
Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?
Study Start Date : July 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Will receive usual wound prevention care, aftercare summaries, and regular surveillance.
Behavioral: Aftercare summary
A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.
No Intervention: 2
Will receive usual wound prevention and surveillance only.
No Intervention: 3
Will receive usual wound prevention only.


Outcome Measures

Primary Outcome Measures :
  1. Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ]

Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]
  2. Change in satisfaction with care [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]
  3. Adherence with self-management goals [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]

Eligibility Criteria

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:

  • Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33);
  • Documented healing of all lower extremity ulcers;
  • Ankle-brachial index (ABI) > 0.8 to rule out arterial insufficiency

Exclusion Criteria:

  • Unwilling or unable to sign informed consent;
  • No plans to seek care at VA Puget Sound within 6 months;
  • Limbs with ulcers or threatened viability
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): NCT00727701


Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98101
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Gayle E. Reiber, MPH PhD VA Puget Sound Health Care System, Seattle
More Information

Responsible Party: Reiber, Gayle - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727701     History of Changes
Other Study ID Numbers: 08-246
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
varicose ulcer
veteran
recurrence
aftercare

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases