Ulcer Monitoring in Diabetes Mellitus

Study Overview
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Brief Summary
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Telemedicine technology enables a direct and online text- and image communication in the treatment system from patient to the ulcer specialist. The technology is expected to have patient-related, economic and therapeutic benefits. The study is a substudy of a larger project entitled Renewing Health, where also the economic and management aspects are highlighted. However, only few randomized prospective studies are conducted in this field. The purpose of the study is in a randomized prospective study, to assess the impact of the introduction of the telemedicine technology as consultation form between ulcer-nurses in the primary sector and the wound clinics at the hospitals in the region. It is assessed whether the technology can be adopted without incurring the patient a risk. The study aims to perform an impact analysis of the introduction of new technologies for telemedicine wound monitoring in the treatment of diabetic foot ulcers through different studies.

Detailed Description
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Through randomized and prospective studies the project will show whether a telemedicine approach to wound care can be used as an alternative to traditional attendance at a wound clinic and document whether this consultation form provides a greater patient-satisfaction and cost savings. The project will document that telemedicine is equivalent to conventional outpatient attendance from a therapeutic aspect in terms of number of hospitalizations, number of extra controls, acute interventions and wound healing. The project is also investigating the extent of time spent on the personnel side using telemedicine consultations compared with conventional outpatient appearances.

Official Title
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Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study

Conditions
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Diabetes Mellitus, Foot Ulcers

Intervention / Treatment
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* Procedure: telemedicine consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having diabetic foot ulcer Referred for out-patient clinic treatment by general practitioner Referred for out-patient clinic treatment by a surgical department Living in Region of Southern Denmark Exclusion Criteria: Psychiatric disorder Dementia Chronic alcohol abuse which can affect compliance Other disorder then diabetes mellitus that have caused foot ulcer (rheumatoid arthritis or arthritis urica) Serious kidney disease which requires dialysis Previous foot ulcer - which was part of the study Expected healing within 2-4 weeks where only one control (final) is expected
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group. Regular treatment. | |
| Experimental: Diabetes ulcer monitoring<br>Receives a telemedicine intervention: Diabetes ulcer monitoring. | Procedure: telemedicine consultations<br>* Replacing 2 out of 3 patient visits to out-patient clinic at hospital with treatment at home from visiting nurse and telemedicine consultations with the specialist doctor.<br>* Other names: pleje.net;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admissions to hospital | The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period. | from time of inclusion until treatment completed, assessed up to 52 weeks | 
| Surgical procedures | The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period. | from time of inclusion until completed treatment, assessed up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing | The time from inclusion and start of treatment until ulcer is healed and treatment is stopped. | Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcer, ulcer monitoring, telemedicine consultations, cross-sectoral collaboration