Diabetic Foot UlcerNCT02086955
Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration
A study testing Nursing counseling in people with Diabetic Foot Ulcer, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation. The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Nursing counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age 18 or older
- in current treatment for ulceration and/or amputation of a lower limb
- are able to understand German oral and in writing
- are able to give written informed consent
Who cannot join
- severe psychiatric diagnoses
- subjects living in dependent living facilities (nursing home or rehabilitation)
- subjects lacking supporting family members and incapable of selfmonitoring their feet due to impairment (vision or physical movement)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Zurich University of Applied Sciences
Winterthur, Canton of Zurich, 8400
Lorenz Imhof, Prf. Dr., ++41 (0)58 934 63 33, lorenz.imhof@zhaw.ch
About this study
The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation.
The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in hospital readmissions for foot-related complication (one year survival probability: failure = readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).
Read the detailed description
Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased peripheral circulation impaired sensation leading to the development of foot ulcers that lead to amputations of toes, feet and limbs. These complications not only have devastating effects on the individual in terms of loss of functionality but also impact the patient's ability to carry out and enjoy occupational, recreational and family functioning activities. Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and loss of productivity. All of these have personal as well as societal economical implications.
This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional patient education program to current management of foot care in patients with DM.
The study aims to test an alternative to current standard of care for patients with foot ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse managed intervention; and if found to be effective, the current study will also allow an evaluation of the cost effectiveness of this intervention and the potential economic reduction in cost to the health care system.
The potential implications are major in terms of quality of life, reduction in morbidity in disability days, and cost savings. It is anticipated that this intervention is at least as effective as hospital stay, and being surrounded by their own loved ones without the threats that a hospital setting presents. The findings will be important to consider whether clinical practice can be changed to benefit patients. If the study results show that the subjects in the IG have better skills in monitoring and treating their diabetic foot ulcerations and eventually avoid developing further complications the intervention can be applied to future patients.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Nursing counseling
- Keywords
- Diabetes, Nursing counseling, Foot ulceration, Outpatient, Advanced Practice Nurse
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing counselingBehavioural
The participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention lasts five weeks. During a period of five weeks, the participants are provided with weekly skill training, and counseling sessions on foot care. Each participant receives a foot care kit with essential foot care material and a foot care diary.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | All participants receive three specially-developed brochures with information regarding the diabetic foot condition. The brochures containes explanations to a) the cause and warning signs of diabetic foot ulcers, b) the precautions patients can take in their daily life, and c) helpful foot gymnastics to be practiced at home. |
| Nursing counseling | Experimental | The participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention go on for five weeks. During a period of five weeks, the participants are provided with weekly education, skill training, and counseling sessions on foot care. Receives: Behavioral: Nursing counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of nurse-led intervention for high risk patients with diabetic foot ulceration/amputation
After the baseline data collection (T0), data will be collected after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4) regarding:
- foot related complications (hospital readmission for ulceration recurrence, new ulcerations or amputations)
Measured: Participants will be followed for the duration of 42 weeks. Data will be collected at baseline (T0) as well as after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Nursing Science Foundation Switzerland
- Responsible party
- Principal investigator, Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences
- Investigators
- Lorenz Imhof, Prof. Dr., Principal investigator, University of applied sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086955
- Sponsor's protocol ID
- 320030_143863
- Other IDs
- 2010-0278/0
- Status last verified
- Jan 2015
- First submitted
- 3 Mar 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration
- ClinicalTrials.gov ID
- NCT02086955
- Acronym / sponsor ID
- 320030_143863
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, Nursing counseling, Foot ulceration, Outpatient, Advanced Practice Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Nursing Science Foundation Switzerland
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 13 Mar 2014 (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.
The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation.
The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in hospital readmissions for foot-related complication (one year survival probability: failure = readmission for ulceration recurrence, new ulcerations, amputation or re-amputation).
Detailed description
Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased peripheral circulation impaired sensation leading to the development of foot ulcers that lead to amputations of toes, feet and limbs. These complications not only have devastating effects on the individual in terms of loss of functionality but also impact the patient's ability to carry out and enjoy occupational, recreational and family functioning activities. Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and loss of productivity. All of these have personal as well as societal economical implications.
This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional patient education program to current management of foot care in patients with DM.
The study aims to test an alternative to current standard of care for patients with foot ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse managed intervention; and if found to be effective, the current study will also allow an evaluation of the cost effectiveness of this intervention and the potential economic reduction in cost to the health care system.
The potential implications are major in terms of quality of life, reduction in morbidity in disability days, and cost savings. It is anticipated that this intervention is at least as effective as hospital stay, and being surrounded by their own loved ones without the threats that a hospital setting presents. The findings will be important to consider whether clinical practice can be changed to benefit patients. If the study results show that the subjects in the IG have better skills in monitoring and treating their diabetic foot ulcerations and eventually avoid developing further complications the intervention can be applied to future patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –All participants receive three specially-developed brochures with information regarding the diabetic foot condition. The brochures containes explanations to a) the cause and warning signs of diabetic foot ulcers, b) the precautions patients can take in their daily life, and c) helpful foot gymnastics to be practiced at home. |
| Nursing counseling | Experimental | Behavioral: Nursing counselingThe participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention go on for five weeks. During a period of five weeks, the participants are provided with weekly education, skill training, and counseling sessions on foot care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients age 18 or older
- in current treatment for ulceration and/or amputation of a lower limb
- are able to understand German oral and in writing
- are able to give written informed consent
Key exclusion criteria (3 listed)
- severe psychiatric diagnoses
- subjects living in dependent living facilities (nursing home or rehabilitation)
- subjects lacking supporting family members and incapable of selfmonitoring their feet due to impairment (vision or physical movement)
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 |
|---|---|---|
| Nursing counselingThe participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention lasts five weeks. During a period of five weeks, the participants are provided with weekly skill training, and counseling sessions on foot care. Each participant receives a foot care kit with essential foot care material and a foot care diary. | Behavioural | Nursing counseling |
Primary outcome
Effectiveness of nurse-led intervention for high risk patients with diabetic foot ulceration/amputation
Time frame: Participants will be followed for the duration of 42 weeks. Data will be collected at baseline (T0) as well as after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4).
After the baseline data collection (T0), data will be collected after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4) regarding: - foot related complications (hospital readmission for ulceration recurrence, new ulcerations or amputations)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
Lorenz Imhof, Prof. Dr. principal investigator
University of applied sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing counseling in people with Diabetic Foot Ulcer, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 3 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Contact Lorenz Imhof, Prof. Dr. (0041589346333, lorenz.imhof@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of nurse-led intervention for high risk patients with diabetic foot ulceration/amputation (time frame: Participants will be followed for the duration of 42 weeks. Data will be collected at baseline (T0) as well as after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.