Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

June 25, 2015 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • VA Puget Sound Health Care System, Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Gayle E. Reiber, MPH PhD, VA Puget Sound Health Care System, Seattle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (ESTIMATE)

August 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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