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

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

Detailed Description
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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.

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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Telemedicine system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine system<br>Telemedicine system | Device: Telemedicine system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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U-health, chronic wound management