Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00727701

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 I

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

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

Department of Veterans Affairs

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
Pathologic Processes
Varicose Veins
Vascular Diseases

Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012