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WithdrawnNCT00761839Updated May 6, 2015

Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

An interventional study of After-care summary and Control group in Wounds, sponsored by US Department of Veterans Affairs. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Study was withdrawn because of a problem with the software used for generating the aftercare summary.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Wounds

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Keywords

  • wound healing
  • self-management
  • patient education
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

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Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

Cognitively impaired patients who cannot give informed consent.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Arm 1

    These patients receive the experimental intervention--the after-care summary.

    Behavioral: After-care summary

  • Active comparator
    Arm 2

    These patients are the control group and receive usual care.

    Behavioral: Control group

Interventions

  • BehavioralAfter-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.

  • BehavioralControl group

    Patients in the control group will receive usual counseling for self-management.

06

What researchers measure

Primary outcomes

  1. patient satisfaction, frequency of self-management activities, time to healing

    Time frame: Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first.

07

Study locations

2 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
    Ann Arbor, Michigan 48105, United States
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    Seattle, Washington 98108, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00761839
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Sep 30, 2008
Start date
Jul 2008
Primary completion
Jun 2009
Completion
Dec 2009
Last update
May 6, 2015

Study contacts

Julie C Lowery, PhD MHSA
principal investigator · VA Ann Arbor Healthcare System, Ann Arbor, MI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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