Diabetic FootDiaFOToNCT01710774
Telemedicine Follow-up in Primary Health Care for Diabetes-related Foot Ulcers
A study testing Telemedicine follow-up care in people with Diabetic Foot and Foot Ulcer, run by Helse Stavanger HF at 3 sites in Norway.
Trial summary
This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot, Foot Ulcer
- What is being tested?
- Telemedicine follow-up care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 3 sitesNorway
- Study dates
- Apr 2012to Dec 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first time within a period of 6 months and people without diabetes presenting a venous leg ulcer
- The participants must be able to read and speak Norwegian.
- The participants must be 20 years or older.
Who cannot join
- people treated for an diabetes foot ulcer on the ipsilateral foot during the past 6 months in specialist health care
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital
Bergen
Stord Hospital, Helse Fonna HF
Leirvik
Stavanger HF
Stavanger, Rogaland, 4068
About this study
Official title: Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial
This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.
Read the detailed description
The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily increasing proportion of older people in the population, will present enormous challenges for health care services and the individual with diabetes in Norway. Therefore, health care services need to rapidly begin treatment for people with diabetes-related foot ulcers to ensure high-quality treatment.
Telemedicine innovations for health care services have developed considerably in recent decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of information and communication technologies is an important way of achieving health policy aims in establishing more integrated diagnosis, treatment and care pathways across organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown that using telemedicine equipment enables follow-up care of similar quality to traditional consultations while enabling more flexible organization and greater patient satisfaction. A few minor quantitative studies show positive gains when telemedicine equipment is used in following up diabetes-related foot ulcers, but no randomized controlled studies have been performed in this field. Further, studies focusing on the more long-term effects are lacking.
The project is in accordance with national guidelines and will contribute to increasing the focus on research related to integrated care. The investigators expect this project to provide evidence about alternative care pathways with a holistic approach that could moderate increases in the cost of health care services by delivering a larger proportion of services in municipal primary care. The project will be able to provide new evidence on meeting the challenges of diabetes-related care more systematically and proactively. The investigators expect that the results of this study will contribute to showing the extent to which treatment at the lowest effective service level will be more cost-effective and of good or better quality than traditional clinical follow-up. This study can and will contribute to setting priorities for the users' needs for flexible health services and enabling more patients to be treated near their homes.
If the study finds evidence of positive health gains for the individual people with diabetes and contributes to high quality of care, this new model can be implemented in the entire Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist health care to be used more appropriately, and the team will be more accessible for health care personnel in municipal primary health care. This model can be transferred to other hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal primary health care.
The main study confirmed that TM was non-inferior in traditional treatment with regard to healing time (primary outcome). The TM group had a significantly lower proportion of amputations, and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group.
There is a need to continue the study with additional patients to gain more knowledge about the extent to which the telemedicine follow-up affects the number of consultations (secondary outcome), inclusion of participants during 2019-2021. In addition, there is a need for more knowledge about the effect of telemedicine follow-up for patients with leg ulcers and in people without diabetes. The investigators have used qualitative interview as a process evaluation in this study and will investigate process variables more systematically in the further follow-up. By examining how the services are organized (organization and structure) the investigators will gain knowledge how the variation in the organization of telemedicine follow-up is affecting the outcome.
- Conditions
- Diabetic Foot, Foot Ulcer
- Being tested
- Telemedicine follow-up care
- Keywords
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer, Wound Healing, Delivery of Health Care, Depression, sequela, Sick Leave, Quality of Life, Amputation, Legg ulcer, Hospitalization, Health Economics
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine follow-up careProcedure or surgery
Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
| Study group | Role | What they receive |
|---|---|---|
| Traditional follow-up | No intervention | Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up. |
| Telemedicine follow-up care | Active comparator | Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care Receives: Procedure: Telemedicine follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time for leg ulcer and/or diabetes related foot ulcer
Healing time for leg ulcer and/or diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as <40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.
Measured: one year
Secondary outcomes (8)
Total number of consultations per patient
Number of consultations from baseline until the foot ulcer has healed
Measured: one year
sequela directly related to the foot ulcer
From baseline until the foot ulcer has healed sequelae directly related to the foot ulcer: infection, hospitalization, osteomyelitis and vascular surgery during the study
Measured: one year
Diabetes-related stress
Diabetes-related stress, measured by using the Problem Areas in Diabetes. Measured at baseline and when the ulcer has healed (or the end of the study)
Measured: one year
Symptoms of anxiety and depression
symptoms of anxiety and depression, measured by using the Hospital Anxiety and Depression Scale at baseline and the end of the study.
Measured: one year
Nordic Patient Experiences Questionnaire
Patient satisfaction with health care, measured by using the Nordic Patient Experiences Questionnaire. Measured at baseline and the end of the study.
Measured: one year
EQ-5D
Health status and cost utility, measured by using the EQ-5D from the EuroQol Group at baseline and the end of the study.
Measured: one year
Sick leave
Sick leave (number of days with a medical certificate) measured by obtaining data from the Norwegian Sick Leave Registry measured from baseline unntil the ulcer is healed (or at the end of the study)
Measured: one year
A new foot ulcer appears, the incidence of amputation and survival.
The time elapsing before a new foot ulcer appears, the incidence of amputation and survival.
Measured: 2 and 3 years after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse Vest, Norwegian Diabetes Association, Bergen University College, The Research Council of Norway, Norwegian Nurses Organisation
- Responsible party
- Sponsor
- Investigators
- Marjolein M. Iversen, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710774
- Sponsor's protocol ID
- SUS-ID210
- Acronym
- DiaFOTo
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2012
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Blytt KM, Kolltveit BH, Graue M, Robberstad M, Ternowitz T, Carlsen S, Iversen MM. The implementation of telemedicine in wound care: a qualitative study of nurses' and patients' experiences. BMC Health Serv Res. 2024 Sep 29;24(1):1146. doi: 10.1186/s12913-024-11620-w.
PubMed 39343892Iversen MM, Igland J, Smith-Strom H, Ostbye T, Tell GS, Skeie S, Cooper JG, Peyrot M, Graue M. Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo). BMC Endocr Disord. 2020 Oct 21;20(1):157. doi: 10.1186/s12902-020-00637-x.
PubMed 33087074Smith-Strom H, Igland J, Ostbye T, Tell GS, Hausken MF, Graue M, Skeie S, Cooper JG, Iversen MM. The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial. Diabetes Care. 2018 Jan;41(1):96-103. doi: 10.2337/dc17-1025. Epub 2017 Nov 29.
PubMed 29187423Smith-Strom H, Iversen MM, Graue M, Skeie S, Kirkevold M. An integrated wound-care pathway, supported by telemedicine, and competent wound management-Essential in follow-up care of adults with diabetic foot ulcers. Int J Med Inform. 2016 Oct;94:59-66. doi: 10.1016/j.ijmedinf.2016.06.020. Epub 2016 Jun 29.
PubMed 27573312Iversen MM, Espehaug B, Hausken MF, Graue M, Ostbye T, Skeie S, Cooper JG, Tell GS, Gunther BE, Dale H, Smith-Strom H, Kolltveit BC, Kirkevold M, Rokne B. Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo). JMIR Res Protoc. 2016 Jul 18;5(3):e148. doi: 10.2196/resprot.5646.
PubMed 27430301Kolltveit BC, Gjengedal E, Graue M, Iversen MM, Thorne S, Kirkevold M. Telemedicine in diabetes foot care delivery: health care professionals' experience. BMC Health Serv Res. 2016 Apr 18;16:134. doi: 10.1186/s12913-016-1377-7.
PubMed 27091459
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01710774
- Acronym / sponsor ID
- DiaFOTo / SUS-ID210
- Conditions
- Diabetic Foot, Foot Ulcer
- Keywords
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer, Wound Healing, Delivery of Health Care, Depression, sequela, Sick Leave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse Vest, Norwegian Diabetes Association, Bergen University College, The Research Council of Norway, Norwegian Nurses Organisation
- Study start
- Apr 2012 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Oct 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.
This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.
Detailed description
The increasing prevalence of diabetes, especially type 2 diabetes, combined with a steadily increasing proportion of older people in the population, will present enormous challenges for health care services and the individual with diabetes in Norway. Therefore, health care services need to rapidly begin treatment for people with diabetes-related foot ulcers to ensure high-quality treatment.
Telemedicine innovations for health care services have developed considerably in recent decades. The National Health Plan for Norway (2007-2010) emphasizes that the use of information and communication technologies is an important way of achieving health policy aims in establishing more integrated diagnosis, treatment and care pathways across organizational boundaries. Qualitative studies of diabetes-related foot ulcers have shown that using telemedicine equipment enables follow-up care of similar quality to traditional consultations while enabling more flexible organization and greater patient satisfaction. A few minor quantitative studies show positive gains when telemedicine equipment is used in following up diabetes-related foot ulcers, but no randomized controlled studies have been performed in this field. Further, studies focusing on the more long-term effects are lacking.
The project is in accordance with national guidelines and will contribute to increasing the focus on research related to integrated care. The investigators expect this project to provide evidence about alternative care pathways with a holistic approach that could moderate increases in the cost of health care services by delivering a larger proportion of services in municipal primary care. The project will be able to provide new evidence on meeting the challenges of diabetes-related care more systematically and proactively. The investigators expect that the results of this study will contribute to showing the extent to which treatment at the lowest effective service level will be more cost-effective and of good or better quality than traditional clinical follow-up. This study can and will contribute to setting priorities for the users' needs for flexible health services and enabling more patients to be treated near their homes.
If the study finds evidence of positive health gains for the individual people with diabetes and contributes to high quality of care, this new model can be implemented in the entire Stavanger Hospital Trust. This approach will enable the multidisciplinary team in specialist health care to be used more appropriately, and the team will be more accessible for health care personnel in municipal primary health care. This model can be transferred to other hospital trusts and contribute to improving knowledge on diabetes among nurses in municipal primary health care.
The main study confirmed that TM was non-inferior in traditional treatment with regard to healing time (primary outcome). The TM group had a significantly lower proportion of amputations, and there were no significant differences in the proportion of deaths, number of consultations, or patient satisfaction between groups, although the direction of the effect estimates for these clinical outcomes favored the TM group.
There is a need to continue the study with additional patients to gain more knowledge about the extent to which the telemedicine follow-up affects the number of consultations (secondary outcome), inclusion of participants during 2019-2021. In addition, there is a need for more knowledge about the effect of telemedicine follow-up for patients with leg ulcers and in people without diabetes. The investigators have used qualitative interview as a process evaluation in this study and will investigate process variables more systematically in the further follow-up. By examining how the services are organized (organization and structure) the investigators will gain knowledge how the variation in the organization of telemedicine follow-up is affecting the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional follow-up | No intervention | –Traditional follow-up with standard consultations at the Section of Endocrinology. For some patients, this will include follow-up from nurses in the home care or general practice office related to wound care. However, this is not the standard procedure and will not take place in combination with telemedicine follow-up. |
| Telemedicine follow-up care | Active comparator | Procedure: Telemedicine follow-up careTelemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- people with type 1 or type 2 diabetes with a new foot ulcer presenting for the first time within a period of 6 months and people without diabetes presenting a venous leg ulcer
- The participants must be able to read and speak Norwegian.
- The participants must be 20 years or older.
Key exclusion criteria (1 listed)
- people treated for an diabetes foot ulcer on the ipsilateral foot during the past 6 months in specialist health care
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 follow-up careTelemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care | Procedure or surgery | Telemedicine follow-up care |
Primary outcome
healing time for leg ulcer and/or diabetes related foot ulcer
Time frame: one year
Healing time for leg ulcer and/or diabetes related foot ulcer measured from the time the person is included in the study until the foot ulcer is healed or the study ends (after 12 months). The effect will be measured in terms of hazard ratios (HR) and sub-hazard ratio (SHR) with healing as the endpoint and non-inferiority will be defined as <40% increased healing time in the TM-group, i.e. the lower 95% confidence limit should not be lower than 0.60.
8 secondary outcomes
Total number of consultations per patient
Time frame: one year
sequela directly related to the foot ulcer
Time frame: one year
Diabetes-related stress
Time frame: one year
Symptoms of anxiety and depression
Time frame: one year
Nordic Patient Experiences Questionnaire
Time frame: one year
EQ-5D
Time frame: one year
Sick leave
Time frame: one year
A new foot ulcer appears, the incidence of amputation and survival.
Time frame: 2 and 3 years after the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 39343892Blytt KM, Kolltveit BH, Graue M, Robberstad M, Ternowitz T, Carlsen S, Iversen MM. The implementation of telemedicine in wound care: a qualitative study of nurses' and patients' experiences. BMC Health Serv Res. 2024 Sep 29;24(1):1146. doi: 10.1186/s12913-024-11620-w.
- Derived from this study: PubMed 33087074Iversen MM, Igland J, Smith-Strom H, Ostbye T, Tell GS, Skeie S, Cooper JG, Peyrot M, Graue M. Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo). BMC Endocr Disord. 2020 Oct 21;20(1):157. doi: 10.1186/s12902-020-00637-x.
- Derived from this study: PubMed 29187423Smith-Strom H, Igland J, Ostbye T, Tell GS, Hausken MF, Graue M, Skeie S, Cooper JG, Iversen MM. The Effect of Telemedicine Follow-up Care on Diabetes-Related Foot Ulcers: A Cluster-Randomized Controlled Noninferiority Trial. Diabetes Care. 2018 Jan;41(1):96-103. doi: 10.2337/dc17-1025. Epub 2017 Nov 29.
- Derived from this study: PubMed 27573312Smith-Strom H, Iversen MM, Graue M, Skeie S, Kirkevold M. An integrated wound-care pathway, supported by telemedicine, and competent wound management-Essential in follow-up care of adults with diabetic foot ulcers. Int J Med Inform. 2016 Oct;94:59-66. doi: 10.1016/j.ijmedinf.2016.06.020. Epub 2016 Jun 29.
- Derived from this study: PubMed 27430301Iversen MM, Espehaug B, Hausken MF, Graue M, Ostbye T, Skeie S, Cooper JG, Tell GS, Gunther BE, Dale H, Smith-Strom H, Kolltveit BC, Kirkevold M, Rokne B. Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo). JMIR Res Protoc. 2016 Jul 18;5(3):e148. doi: 10.2196/resprot.5646.
- Derived from this study: PubMed 27091459Kolltveit BC, Gjengedal E, Graue M, Iversen MM, Thorne S, Kirkevold M. Telemedicine in diabetes foot care delivery: health care professionals' experience. BMC Health Serv Res. 2016 Apr 18;16:134. doi: 10.1186/s12913-016-1377-7.
- Individual participant dataSharing planned: No
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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.
Marjolein M. Iversen, PhD principal investigator
Helse Stavanger HF
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine follow-up care in people with Diabetic Foot and Foot Ulcer, run by Helse Stavanger HF at 3 sites in Norway.
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 3 inclusion and 1 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing time for leg ulcer and/or diabetes related foot ulcer (time frame: one year). 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 NCT01710774, which also lists 6 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 21 Apr 2023.