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Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT00727701
Collaborator
(none)
72
Enrollment
1
Location
3
Arms
11
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Aftercare summary
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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?
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Ulcer-free survival period [Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)]

Secondary Outcome Measures

  1. Change in quality of life [Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.]

  2. Change in satisfaction with care [Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.]

  3. Adherence with self-management goals [Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VA Puget Sound Health Care System, Seattle Seattle Washington United States 98101

Sponsors and Collaborators

  • US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00727701
Other Study ID Numbers:
  • 08-246
First Posted:
Aug 4, 2008
Last Update Posted:
Jun 26, 2015
Last Verified:
Jun 1, 2015
Keywords provided by , ,
varicose ulcer
veteran
recurrence
aftercare
Additional relevant MeSH terms:
Varicose Ulcer
Ulcer

Study Results

No Results Posted as of Jun 26, 2015