Ulcer Monitoring in Diabetes Mellitus — Telesaar  

Diabetes Mellitus Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Foot Ulcer
• Foot Ulcers
• Ulcer

• NCT number: NCT01608425
• Study type: Interventional
• Source: Odense University Hospital
• Contact: Benjamin S. Rasmussen, MD
• Phone: 004560774050
• Email: benjamin.schnack.rasmussen@ouh.regionsyddanmark.dk
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2011
• Completion date: November 2013