Ulcer Monitoring in Diabetes Mellitus
Telesaar
Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
1 other identifier
interventional
400
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus
Started Apr 2011
Typical duration for phase_2 diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJune 5, 2013
June 1, 2013
2.2 years
May 24, 2012
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Ulcer healing
Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks
Study Arms (2)
Control
NO INTERVENTIONControl group. Regular treatment.
Diabetes ulcer monitoring
EXPERIMENTALReceives a telemedicine intervention: Diabetes ulcer monitoring.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johnny Froekjaerlead
- Region of Southern Denmarkcollaborator
- European Commissioncollaborator
Study Sites (6)
South-west Hospital
Esbjerg, Region Syddanmark, 6700, Denmark
Lillebaelt Hospital
Kolding, Region Syddanmark, 6000, Denmark
Odense University Hospital
Odense, Region Syddanmark, 5000, Denmark
Svendborg Hospital
Svendborg, Region Syddanmark, 5700, Denmark
Hospital South Jutland
Sønderborg, Region Syddanmark, 6400, Denmark
Hospital Lillebaelt
Vejle, Region Syddanmark, 7100, Denmark
Related Publications (2)
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.
PMID: 27638453DERIVEDRasmussen 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.
PMID: 26116717DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Benjamin S. Rasmussen, MD
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Johnny Froekjaer, MD
Odense University Hospital
- STUDY CHAIR
Knud B. Yderstraede, MD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research responsible Chief Surgeon
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 31, 2012
Study Start
April 1, 2011
Primary Completion
June 1, 2013
Study Completion
November 1, 2013
Last Updated
June 5, 2013
Record last verified: 2013-06