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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382302
• Other study ID #: E-1106/063-005
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: March 2, 2015
• Start date: July 2011
• Est. completion date: February 2012

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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

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.

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
Primary	Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	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.	4weeks post-treatment	Yes
Secondary	Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	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.	1week post-treatment	Yes
Secondary	Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	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.	2weeks post-treatment	Yes
Secondary	Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	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.	3weeks post-treatment	Yes