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Pressure Ulcer Assessment Via Telemedicine
This study has been completed.
First Received: March 14, 2001   Last Updated: January 30, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012597
  Purpose

A Web-based telemedicine system for monitoring the status of patients with pressure ulcers has been developed. It consists of three major data collection components: (1) digital photograph of ulcer; (2) quantitative measurements of wound status (i.e., ulcer area and volume, skin elasticity); and (3) other wound and patient data collected by a nurse. Data are collected via laptop computer and transmitted to a central database, where a computer program transforms the data into the necessary reporting format. The output is posted onto a World Wide Web page for access by the consulting physician. The system incorporates all data requirements for assessment recommended by AHCPR's Clinical Practice Guideline, �Treatment of Pressure Ulcers.�


Condition Intervention
Pressure Ulcers
Procedure: Web-based telemedicine system for assessment of status of pressure ulcers

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Pressure Ulcer Assessment Via Telemedicine

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 128
Study Completion Date: September 2000
Arms Assigned Interventions
1 Procedure: Web-based telemedicine system for assessment of status of pressure ulcers

Detailed Description:

Background:

A Web-based telemedicine system for monitoring the status of patients with pressure ulcers has been developed. It consists of three major data collection components: (1) digital photograph of ulcer; (2) quantitative measurements of wound status (i.e., ulcer area and volume, skin elasticity); and (3) other wound and patient data collected by a nurse. Data are collected via laptop computer and transmitted to a central database, where a computer program transforms the data into the necessary reporting format. The output is posted onto a World Wide Web page for access by the consulting physician. The system incorporates all data requirements for assessment recommended by AHCPR's Clinical Practice Guideline, �Treatment of Pressure Ulcers.�

Objectives:

The primary objective of this pilot study was to evaluate the clinical accuracy of a telemedicine system for assessing the status of pressure ulcers, both chronic and those which have been surgically repaired. The principal hypotheses were: (1) use of the telemedicine system results in the same diagnoses as does in-person patient assessment; and (2) patients are satisfied with the telemedicine system.

Methods:

Two VA medical centers and two specialties participated in the study: Ann Arbor (plastic surgery) and Augusta (plastic surgery, physical medicine and rehabilitation). They contributed inpatients and outpatients with a pressure ulcer of stage II, III, or IV over a one-year enrollment period. All study patients were assessed both in-person (the "gold standard") and with the telemedicine system. The in-person and telemedicine physicians provided yes/no responses to four diagnostic questions concerning wound healing and infection, based on AHCPR guidelines, and they were blinded to each other�s assessments. Patient satisfaction data were collected using a specially designed, self-administered questionnaire to measure perceptions regarding the burden of the telemedicine system, confidence in the evaluation, and absence of direct contact with a physician.

Status:

Ongoing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

VA inpatients, outpatients, or nursing home residents at the participating sites who have any of the following wounds: (1) chronic pressure ulcers at stage II, III or IV; (2) post-operative wound patients having undergone a skin flap procedure for a grade III or IV pressure ulcer; (3) diabetic wounds; (4) arterial ulcers; or (5) chronic venous status ulcers. Exclusion criteria: Mentally incompetent patients.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012597

Locations
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Julie C. Lowery, PhD MHSA VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Lowery, Julie - Principal Investigator )
Study ID Numbers: ACC 97-013
Study First Received: March 14, 2001
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00012597     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

ClinicalTrials.gov processed this record on May 06, 2009