Diabetes Mellitus, Foot Ulcers
Conditions
Keywords
diabetic foot ulcer, ulcer monitoring, telemedicine consultations, cross-sectoral collaboration
Brief 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.
Detailed 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.
Interventions
PROCEDUREtelemedicine consultations
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.
Sponsors
Region of Southern Denmark
European Commission
Johnny Froekjaer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Admissions to hospital | from time of inclusion until treatment completed, assessed up to 52 weeks | The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period. |
| Surgical procedures | from time of inclusion until completed treatment, assessed up to 52 weeks | The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing | Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks | The time from inclusion and start of treatment until ulcer is healed and treatment is stopped. |
Countries
Denmark
Contacts
Primary ContactBenjamin S. Rasmussen, MD
Outcome results
None listed