Pressure UlcerNCT02382302
Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management
A study testing Telemedicine system in people with Pressure Ulcer, run by Chan-Yeong Heo at 1 site in South Korea.
Trial summary
This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the 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?
- Telemedicine system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Feb 2012
- 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
- Subjects who have pressure ulcer
- Subjects who voluntarily decided the participation of the study and signed the informed consent
Who cannot join
- Subjects who have Osteomyelitis
- Subjects who have suppuration
- Subjects 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: A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer
This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.
Read the detailed 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.
- Conditions
- Pressure Ulcer
- Being tested
- Telemedicine system
- Keywords
- U-health, chronic wound management
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine system | Experimental | Telemedicine system Receives: Device: Telemedicine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4weeks post-treatment
Secondary outcomes (3)
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.
Measured: 1week post-treatment
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.
Measured: 2weeks post-treatment
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.
Measured: 3weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionFeb 2012
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
- 20 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
- NCT02382302
- Sponsor's protocol ID
- E-1106/063-005
- Status last verified
- Mar 2015
- First submitted
- 17 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer
- ClinicalTrials.gov ID
- NCT02382302
- Acronym / sponsor ID
- E-1106/063-005
- Conditions
- Pressure Ulcer
- Keywords
- U-health, chronic wound management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chan-Yeong HeoUniversity, hospital or other
- Collaborators
- KT Corporation
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 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.
This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.
Detailed 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.
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 |
|---|---|---|
| Telemedicine system | Experimental | Device: Telemedicine systemTelemedicine system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have pressure ulcer
- Subjects who voluntarily decided the participation of the study and signed the informed consent
Key exclusion criteria (3 listed)
- Subjects who have Osteomyelitis
- Subjects who have suppuration
- Subjects 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 |
|---|---|---|
| Telemedicine systemThe 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. | Device | Telemedicine system |
Primary outcome
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time frame: 4weeks post-treatment
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.
3 secondary outcomes
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time frame: 1week post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time frame: 2weeks post-treatment
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
Time frame: 3weeks 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 6 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 Telemedicine system 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 2 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 6 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 for the wound and the type of dressing on the Pressure Sore Status Tool (PSST) (time frame: 4weeks 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 6 Mar 2015.