Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management

March 2, 2015 updated by: Chan-Yeong Heo

A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer

This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have pressure ulcer
  • Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria:

  • Subjects who have Osteomyelitis
  • Subjects who have suppuration
  • Subjects who participated in other clinical trial within 30 days from screening date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine system
Device: Telemedicine system
The data such as photographs can be collected simply using built-in cameras installed in smart-phones that used the standard touch-screen user interface (UI) and camera installed in the iPhone3GS and iPhone4 using iOS 3.0 and iOS 5.0, respectively. Subjects were instructed to transmit the photographs of the wounds then investigator performed the photography in such a manner that the size of pressure ulcer should be automatically measured based on a 1 cm x 1 cm-sized indicator on the screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time Frame: 4weeks post-treatment

  1. Data collection

    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer

  2. Remote physician monitoring

    - The patient data was transmitted from the smart-phone to the website via open application programming interface (API)

  3. Prescription
  4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
4weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time Frame: 1week post-treatment

  1. Data collection

    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer

  2. Remote physician monitoring

    - The patient data was transmitted from the smart-phone to the website via open application programming interface (API)

  3. Prescription
  4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
1week post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time Frame: 2weeks post-treatment

  1. Data collection

    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer

  2. Remote physician monitoring

    - The patient data was transmitted from the smart-phone to the website via open application programming interface (API)

  3. Prescription
  4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
2weeks post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time Frame: 3weeks post-treatment

  1. Data collection

    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer

  2. Remote physician monitoring

    - The patient data was transmitted from the smart-phone to the website via open application programming interface (API)

  3. Prescription
  4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.
3weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chan-Yeong Heo

Collaborators

KT Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1106/063-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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