Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

This study has been 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.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00727701
First received: July 30, 2008
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Varicose Ulcer
Behavioral: Aftercare summary
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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?

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
  • Change in satisfaction with care [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
  • Adherence with self-management goals [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727701

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

No publications provided

Responsible Party: Reiber, Gayle - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00727701     History of Changes
Other Study ID Numbers: 08-246
Study First Received: July 30, 2008
Last Updated: July 23, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
varicose ulcer
veteran
recurrence
aftercare

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

ClinicalTrials.gov processed this record on October 20, 2014