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

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: Pressure Ulcer
• Intervention / Treatment: Device: Telemedicine system

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	Data collectionThe measurement of the size of pressure ulcerMedical 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.	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)	Data collectionThe measurement of the size of pressure ulcerMedical 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.	1week post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	Data collectionThe measurement of the size of pressure ulcerMedical 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.	2weeks post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	Data collectionThe measurement of the size of pressure ulcerMedical 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.	3weeks post-treatment

Collaborators and Investigators

• Sponsor: Chan-Yeong Heo
• Collaborators: KT Corporation

Study record dates

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: chronic wound management; U-health
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: E-1106/063-005