Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Completed NCT02865902 - Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness N/A
Terminated NCT01191567 - Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Recruiting NCT00737425 - Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery Phase 4
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Terminated NCT00762138 - The AutoloGelâ„¢ Post-Market Surveillance (TAPS) Program N/A
Withdrawn NCT00234559 - Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Completed NCT02591537 - OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University N/A
Completed NCT00792688 - Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation Phase 2
Recruiting NCT05608317 - A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing N/A
Recruiting NCT02195063 - Survey Study for Pain Management, Wound Care, Scar Care or UDT Phase 4
Completed NCT01319149 - A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes N/A
Completed NCT00153452 - Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners N/A
Completed NCT06083740 - A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2
Withdrawn NCT02314416 - Stem Cells In Wound Healing With Collagen Matrix as a Carrier Phase 4
Recruiting NCT01454167 - Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications N/A