Ulcer Monitoring in Diabetes Mellitus

Phase 2

• Conditions: Diabetes Mellitus; Foot Ulcers
• Interventions: Procedure: telemedicine consultations

• Registration Number: NCT01608425
• Lead Sponsor: Johnny Froekjaer

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-28
• Study First Posted: 2012-05-31
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes ulcer monitoring	telemedicine consultations	Receives a telemedicine intervention: Diabetes ulcer monitoring.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Hospital Lillebaelt; 🇩🇰 Vejle, Region of Southern Denmark, Denmark

Svendborg Hospital; 🇩🇰 Svendborg, Region of Southern Denmark, Denmark

Odense University Hospital; 🇩🇰 Odense, Region of Southern Denmark, Denmark

Hospital South Jutland; 🇩🇰 Soenderborg, Region of Southern Denmark, Denmark

South-west Hospital; 🇩🇰 Esbjerg, Region of Southern Denmark, Denmark

Lillebaelt Hospital; 🇩🇰 Kolding, Region of Southern Denmark, Denmark