Pressure UlcerNCT02385942
KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research
A study testing Smart phone in people with Pressure Ulcer, run by Chan-Yeong Heo at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Smart phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who has pressure ulcer or Health care provider for wound management
Who cannot join
- Subject who have Osteomyelitis
- Subject who have suppuration
- Subject who participated in other clinical trial within 30 days from screening date
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: KT-SNUBH U-health Cooperative Research: Target Selection and Consumers' Intention Research for Commercialization of the Pressure Ulcer Management u-Health Solution
The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.
Read the detailed 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.
- Conditions
- Pressure Ulcer
- Being tested
- Smart phone
- Keywords
- u-health, chronic wound management, pressure ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart phoneDevice
- measure the Live assessed wound size and the transmitted Smart phone-based wound size
- determine dressing materials using Smart phone-based tele-consultation
| Study group | Role | What they receive |
|---|---|---|
| Tele-consultation system | Other | compare the Live assessed wound size with the transmitted Smart phone-based wound size through Tele-consultation system Receives: Device: Smart phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance rate of wound size between live assessed wound size and transmitted wound size
Measured: a week from post treatment
Secondary outcomes (3)
concordance rate of wound size between live assessed wound size and transmitted wound size
Measured: 2 weeks from post treatment
concordance rate of wound size between live assessed wound size and transmitted wound size
Measured: 3 weeks from post treatment
concordance rate of wound size between live assessed wound size and transmitted wound size
Measured: 4 weeks from post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chan-Yeong Heo
- Sponsor type
- University, hospital or other
- Collaborators
- KT Corporation
- Responsible party
- Sponsor-investigator, Chan-Yeong Heo, Seoul National University Hospital
- Investigators
- Chanyeong Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385942
- Sponsor's protocol ID
- E-1206/158-001
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KT-SNUBH U-health Cooperative Research: Target Selection and Consumers' Intention Research for Commercialization of the Pressure Ulcer Management u-Health Solution
- ClinicalTrials.gov ID
- NCT02385942
- Acronym / sponsor ID
- E-1206/158-001
- Conditions
- Pressure Ulcer
- Keywords
- u-health, chronic wound management, pressure ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chan-Yeong HeoUniversity, hospital or other
- Collaborators
- KT Corporation
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-consultation system | Other | Device: Smart phonecompare the Live assessed wound size with the transmitted Smart phone-based wound size through Tele-consultation system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject who has pressure ulcer or Health care provider for wound management
Key exclusion criteria (3 listed)
- Subject who have Osteomyelitis
- Subject who have suppuration
- Subject who participated in other clinical trial within 30 days from screening date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Tele-consultation system |
Primary outcome
concordance rate of wound size between live assessed wound size and transmitted wound size
Time frame: a week from post treatment
3 secondary outcomes
concordance rate of wound size between live assessed wound size and transmitted wound size
Time frame: 2 weeks from post treatment
concordance rate of wound size between live assessed wound size and transmitted wound size
Time frame: 3 weeks from post treatment
concordance rate of wound size between live assessed wound size and transmitted wound size
Time frame: 4 weeks from post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart phone in people with Pressure Ulcer, run by Chan-Yeong Heo at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance rate of wound size between live assessed wound size and transmitted wound size (time frame: a week from post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.