Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?

Conditions
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Varicose Ulcer

Intervention / Treatment
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* Behavioral: Aftercare summary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer-free survival period |  | Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life |  | Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. | 
| Change in satisfaction with care |  | Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. | 
| Adherence with self-management goals |  | Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose ulcer, veteran, recurrence, aftercare