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
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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
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 Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013