KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research

Pressure Ulcer Clinical Trial

Official title:

KT-SNUBH U-health Cooperative Research: Target Selection and Consumers' Intention Research for Commercialization of the Pressure Ulcer Management u-Health Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385942
• Other study ID #: E-1206/158-001
• Status: Completed
• Phase: N/A
• First received: March 3, 2015
• Last updated: March 10, 2015
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.

Description:

In this study, 'the management of pressure ulcer' defined as procedures comprising wound assessment, wound dressing and infection control, visually evaluated the outcomes of 'the management of pressure ulcer' through the tele-consultation.

This study designed to draw service targets based on utility and compatibility of U-health solution service and to analyse whether health providers use U-health solution service.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subject who has pressure ulcer or Health care provider for wound management

Exclusion Criteria:

• Subject who have Osteomyelitis

• Subject who have suppuration

• Subject who participated in other clinical trial within 30 days from screening date

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Device:
• Smart phone
measure the Live assessed wound size and the transmitted Smart phone-based wound size determine dressing materials using Smart phone-based tele-consultation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Chan-Yeong Heo	KT Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction degree of the tele-consultation as measured by questionnaire.		4 weeks from post treatment	No
Other	Usability survey		4 weeks from post treatment	No
Primary	concordance rate of wound size between live assessed wound size and transmitted wound size		a week from post treatment	Yes
Secondary	concordance rate of wound size between live assessed wound size and transmitted wound size		2 weeks from post treatment	Yes
Secondary	concordance rate of wound size between live assessed wound size and transmitted wound size		3 weeks from post treatment	Yes
Secondary	concordance rate of wound size between live assessed wound size and transmitted wound size		4 weeks from post treatment	Yes