Ulcer Monitoring in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— Telesaar  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01608425
• Other study ID #: Telesaar RH_3
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2012
• Last updated: June 4, 2013
• Start date: April 2011
• Est. completion date: November 2013

Study information

• Verified date: June 2013
• Source: Odense University Hospital
• Contact: Benjamin S. Rasmussen, MD
• Phone: 004560774050
• Email: benjamin.schnack.rasmussen[@]ouh.regionsyddanmark.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

Procedure:
• telemedicine 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.

Locations

Country	Name	City	State
Denmark	South-west Hospital	Esbjerg	Region of Southern Denmark
Denmark	Lillebaelt Hospital	Kolding	Region of Southern Denmark
Denmark	Odense University Hospital	Odense	Region of Southern Denmark
Denmark	Hospital South Jutland	Soenderborg	Region of Southern Denmark
Denmark	Svendborg Hospital	Svendborg	Region of Southern Denmark
Denmark	Hospital Lillebaelt	Vejle	Region of Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
Johnny Froekjaer	European Commission, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Ulcer healing	The time from inclusion and start of treatment until ulcer is healed and treatment is stopped.	Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks	Yes

External Links

•   More information about the clinical study as part of a EU funded project