Full Text View
Tabular View
No Study Results Posted
Related Studies
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. )
Study NCT00727701   Information provided by Department of Veterans Affairs
First Received: July 30, 2008   Last Updated: July 23, 2009   History of Changes

July 30, 2008
July 23, 2009
July 2008
June 2009   (final data collection date for primary outcome measure)
Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00727701 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development
Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?

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.

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.

Phase I
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Varicose Ulcer
Behavioral: Aftercare summary
  • Experimental: Will receive usual wound prevention care, aftercare summaries, and regular surveillance.
  • No Intervention: Will receive usual wound prevention and surveillance only.
  • No Intervention: Will receive usual wound prevention only.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
0
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00727701
Reiber, Gayle - Principal Investigator, Department of Veterans Affairs
08-246
Department of Veterans Affairs
 
Principal Investigator: Gayle E. Reiber, MPH PhD VA Puget Sound Health Care System, Seattle
Department of Veterans Affairs
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP