NCT02385942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

March 3, 2015

Last Update Submit

March 10, 2015

Conditions

Keywords

u-healthchronic wound managementpressure ulcer

Outcome Measures

Primary Outcomes (1)

  • concordance rate of wound size between live assessed wound size and transmitted wound size

    a week from post treatment

Secondary Outcomes (3)

  • concordance rate of wound size between live assessed wound size and transmitted wound size

    2 weeks from post treatment

  • concordance rate of wound size between live assessed wound size and transmitted wound size

    3 weeks from post treatment

  • concordance rate of wound size between live assessed wound size and transmitted wound size

    4 weeks from post treatment

Other Outcomes (2)

  • Satisfaction degree of the tele-consultation as measured by questionnaire.

    4 weeks from post treatment

  • Usability survey

    4 weeks from post treatment

Study Arms (1)

Tele-consultation system

OTHER

compare the Live assessed wound size with the transmitted Smart phone-based wound size through Tele-consultation system

Device: Smart phone

Interventions

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

Tele-consultation system

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 UlcerSkin DiseasesSkin 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

March 3, 2015

First Posted

March 11, 2015

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations