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Completed

NCT Number: NCT02382302

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

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

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine System

Device

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.

Primary outcomes

  1. Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)

    Time frame: 4weeks post-treatment

    • Data collection
    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer
    • Remote physician monitoring
    • The patient data was transmitted from the smart-phone to the website via open application programming interface (API)
    • Prescription
    • 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.

Secondary outcomes

  1. Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)

    Time frame: 1week post-treatment

    • Data collection
    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer
    • Remote physician monitoring
    • The patient data was transmitted from the smart-phone to the website via open application programming interface (API)
    • Prescription
    • 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.

  2. Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)

    Time frame: 2weeks post-treatment

    • Data collection
    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer
    • Remote physician monitoring
    • The patient data was transmitted from the smart-phone to the website via open application programming interface (API)
    • Prescription
    • 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.

  3. Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)

    Time frame: 3weeks post-treatment

    • Data collection
    • The measurement of the size of pressure ulcer
    • Medical examination;the degree of recovery of pressure ulcer
    • Remote physician monitoring
    • The patient data was transmitted from the smart-phone to the website via open application programming interface (API)
    • Prescription
    • 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.

Sponsors and collaborators

Lead sponsor

Chan-Yeong Heo

Other

Collaborators

  • KT Corporation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2015
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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