Ulcer Monitoring in Diabetes Mellitus (Telesaar)

Johnny Froekjaer

Status and phase

Unknown

Phase 2

Conditions

Foot Ulcers

Diabetes Mellitus

Treatments

Procedure: telemedicine consultations

Study type

Interventional

Funder types

Other

Identifiers

NCT01608425

Telesaar RH_3

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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