Clinical trial NCT01608425: Ulcer Monitoring in Diabetes Mellitus
Official title: Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus
Foot Ulcers
Keywords: diabetic foot ulcer
ulcer monitoring
telemedicine consultations
cross-sectoral collaboration
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: European Commission
First posted: 2012-05-31
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Admissions to hospital
timeFrame: from time of inclusion until treatment completed, assessed up to 52 weeks
measure: Surgical procedures
timeFrame: from time of inclusion until completed treatment, assessed up to 52 weeks
Secondary outcomes:
measure: Ulcer healing
timeFrame: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: South-west Hospital
state: Region of Southern Denmark
city: Kolding
country: Denmark
facility: Lillebaelt Hospital
state: Region of Southern Denmark
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region of Southern Denmark
city: Soenderborg
country: Denmark
facility: Hospital South Jutland
state: Region of Southern Denmark
city: Svendborg
country: Denmark
facility: Svendborg Hospital
state: Region of Southern Denmark
city: Vejle
country: Denmark
facility: Hospital Lillebaelt
state: Region of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Benjamin S. Rasmussen, MD
role: STUDY_DIRECTOR
affiliation: Odense University Hospital
name: Johnny Froekjaer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Knud B. Yderstraede, MD
role: STUDY_CHAIR
References:
citation: Fasterholdt I, Gerstrom M, Rasmussen BSB, Yderstraede KB, Kidholm K, Pedersen KM. Cost-effectiveness of telemonitoring of diabetic foot ulcer patients. Health Informatics J. 2018 Sep;24(3):245-258. doi: 10.1177/1460458216663026. Epub 2016 Sep 16.
citation: Rasmussen BS, Froekjaer J, Bjerregaard MR, Lauritsen J, Hangaard J, Henriksen CW, Halekoh U, Yderstraede KB. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care. 2015 Sep;38(9):1723-9. doi: 10.2337/dc15-0332. Epub 2015 Jun 26.