Diabetes MellitusPhase 2TelesaarNCT01608425
Ulcer Monitoring in Diabetes Mellitus
A Phase 2 study testing telemedicine consultations in people with Diabetes Mellitus and Foot Ulcers, run by Johnny Froekjaer at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Foot Ulcers
- What is being tested?
- telemedicine consultations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesDenmark
- Study dates
- Apr 2011to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
South-west Hospital
Esbjerg, Region Syddanmark, 6700
- Recruiting
Lillebaelt Hospital
Kolding, Region Syddanmark, 6000
- Recruiting
Odense University Hospital
Odense, Region Syddanmark, 5000
- Recruiting
Hospital South Jutland
Sønderborg, Region Syddanmark, 6400
- Recruiting
Svendborg Hospital
Svendborg, Region Syddanmark, 5700
- Recruiting
Hospital Lillebaelt
Vejle, Region Syddanmark, 7100
About this study
Official title: Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Foot Ulcers
- Being tested
- telemedicine consultations
- Keywords
- diabetic foot ulcer, ulcer monitoring, telemedicine consultations, cross-sectoral collaboration
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicine consultationsProcedure or surgery
Also called pleje.net
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group. Regular treatment. |
| Diabetes ulcer monitoring | Experimental | Receives a telemedicine intervention: Diabetes ulcer monitoring. Receives: Procedure: telemedicine consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admissions to hospital
The number of admissions, incl, beddays, to hospital relating to ulcer treatment for each randomised patient during the treatment period.
Measured: 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.
Measured: from time of inclusion until completed treatment, assessed up to 52 weeks
Secondary outcomes (1)
Ulcer healing
The time from inclusion and start of treatment until ulcer is healed and treatment is stopped.
Measured: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnny Froekjaer
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, European Commission
- Responsible party
- Sponsor-investigator, Johnny Froekjaer, Odense University Hospital
- Investigators
- Benjamin S. Rasmussen, MD, Study director, Odense University HospitalJohnny Froekjaer, MD, Principal investigator, Odense University HospitalKnud B. Yderstraede, MD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608425
- Sponsor's protocol ID
- Telesaar RH_3
- Acronym
- Telesaar
- Status last verified
- Jun 2013
- First submitted
- 24 May 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27638453Rasmussen 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.
PubMed 26116717
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment by Introducing Telemedicine Consultations for Treatment of Diabetic Patients With Foot Ulcers in Region of Southern Denmark - Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT01608425
- Acronym / sponsor ID
- Telesaar / Telesaar RH_3
- Conditions
- Diabetes Mellitus, Foot Ulcers
- Keywords
- diabetic foot ulcer, ulcer monitoring, telemedicine consultations, cross-sectoral collaboration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johnny FroekjaerUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, European Commission
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group. Regular treatment. |
| Diabetes ulcer monitoring | Experimental | Procedure: telemedicine consultationsReceives a telemedicine intervention: Diabetes ulcer monitoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedicine consultationsAlso: pleje.netReplacing 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. | Procedure or surgery | Diabetes ulcer monitoring |
Primary outcome
Admissions to hospital
Time frame: 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
Time frame: 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.
1 secondary outcome
Ulcer healing
Time frame: Progress is measured at minimum every 4 weeks during treatment period, assessed up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Derived from this study: PubMed 27638453Fasterholdt 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.
- Derived from this study: PubMed 26116717Rasmussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin S. Rasmussen, MD study director
Odense University Hospital
Johnny Froekjaer, MD principal investigator
Odense University Hospital
Knud B. Yderstraede, MD study chair
Odense University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telemedicine consultations in people with Diabetes Mellitus and Foot Ulcers, run by Johnny Froekjaer at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin S. Rasmussen, MD (004560774050, benjamin.schnack.rasmussen@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admissions to hospital (time frame: from time of inclusion until treatment completed, assessed up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.