Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Varicose Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Will receive usual wound prevention care, aftercare summaries, and regular surveillance.

Group Type EXPERIMENTAL

Aftercare summary

Intervention Type BEHAVIORAL

A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.

2

Will receive usual wound prevention and surveillance only.

Group Type NO_INTERVENTION

No interventions assigned to this group

3

Will receive usual wound prevention only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No