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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00761839
Other study ID # XVA 41-027
Secondary ID
Status Withdrawn
Phase N/A
First received September 29, 2008
Last updated May 5, 2015
Start date July 2008
Est. completion date December 2009

Study information

Verified date May 2015
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate a patient education program for chronic wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound self-management "after-care summary" with approximately half of her patients. This study will examine whether using this patient education tool for self-management of wound care results in improved patient outcomes.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

All patients presenting for outpatient wound care at the Ann Arbor VA Medical Center NP wound care clinic, who meet the following inclusion criteria for chronic wounds: stage II, III, IV pressure ulcers; venous stasis ulcers, and diabetic ulcers.

Exclusion Criteria:

Cognitively impaired patients who cannot give informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
After-care summary
The wound care NP will measure the wound and assess adherence to the following self-management activities: visiting the wound care clinic as scheduled; offloading; applying dressings; obtaining assistance at home; and participating in social activities. This information will be entered into a computer database on a VA computer that will generate a summary chart showing the relationship between adherence and wound healing. The generated "after-care summary" will be discussed with the patient and used to set self-management goals.
Control group
Patients in the control group will receive usual counseling for self-management.

Locations

Country Name City State
United States VA Ann Arbor Healthcare System, Ann Arbor, MI Ann Arbor Michigan
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient satisfaction, frequency of self-management activities, time to healing Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first. No
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