Ulcer Monitoring in Diabetes Mellitus (Telesaar)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Foot Ulcers |
Procedure: telemedicine consultations |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study |
- Admissions to hospital [ Time Frame: from time of inclusion until treatment completed, assessed up to 52 weeks ] [ Designated as safety issue: Yes ]The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period.
- Surgical procedures [ Time Frame: from time of inclusion until completed treatment, assessed up to 52 weeks ] [ Designated as safety issue: Yes ]The number of surgical procedures (incl. amputations) performed at hospital in realtion to the ulcer during the treatment period.
- Ulcer healing [ Time Frame: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks ] [ Designated as safety issue: Yes ]The time from inclusion and start of treatment until ulcer is healed and treatment is stopped.
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Control group. Regular treatment.
|
|
|
Experimental: Diabetes ulcer monitoring
Receives a telemedicine intervention: Diabetes ulcer monitoring.
|
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.
Other Name: pleje.net
|
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| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Benjamin S. Rasmussen, MD | 004560774050 | benjamin.schnack.rasmussen@ouh.regionsyddanmark.dk |
| Denmark | |
| South-west Hospital | Recruiting |
| Esbjerg, Region of Southern Denmark, Denmark, 6700 | |
| Lillebaelt Hospital | Recruiting |
| Kolding, Region of Southern Denmark, Denmark, 6000 | |
| Odense University Hospital | Recruiting |
| Odense, Region of Southern Denmark, Denmark, 5000 | |
| Hospital South Jutland | Recruiting |
| Soenderborg, Region of Southern Denmark, Denmark, 6400 | |
| Svendborg Hospital | Recruiting |
| Svendborg, Region of Southern Denmark, Denmark, 5700 | |
| Hospital Lillebaelt | Recruiting |
| Vejle, Region of Southern Denmark, Denmark, 7100 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Johnny Froekjaer, Research responsible Chief Surgeon, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT01608425 History of Changes |
| Other Study ID Numbers: | Telesaar RH_3 |
| Study First Received: | May 24, 2012 |
| Last Updated: | May 28, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Odense University Hospital:
|
diabetic foot ulcer ulcer monitoring telemedicine consultations cross-sectoral collaboration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Ulcer Foot Ulcer Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
ClinicalTrials.gov processed this record on May 19, 2013