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

NCT02382302 | Completed

• 1 other identifier: E-1106/063-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcer

Keywords

U-health; chronic wound management

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

  1week post-treatment

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

  2weeks post-treatment

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

  3weeks post-treatment

Study Arms (1)

Telemedicine system

EXPERIMENTAL

Telemedicine system

Device: Telemedicine system

Interventions

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.

Telemedicine system

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chan-Yeong Heo: lead
• KT Corporation: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ChanYeong Heo, Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 6, 2015
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

KR (1)