Diabetic Foot UlcerNCT01731808
Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
A study testing Nursing counseling in people with Diabetic Foot Ulcer, run by Zurich University of Applied Sciences at 5 sites in Switzerland.
Trial summary
The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration. 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
- 19 participants
- Where
- 5 sitesSwitzerland
- Study dates
- Oct 2010to Mar 2013
- 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 with
- current treatment for ulceration and/or amputation of a lower limb
- stable wound healing
- no signs of wound infection
- stable diabetes
- manageable pain
Who cannot join
- patients with cognitive impairment and psychiatric diseases
- patients living in dependent living facilities
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Kantonsspital Frauenfeld
Frauenfeld, 8501
Luzerner Kantonsspital
Lucerne, 6000
Kantonsspital Winterthur
Winterthur, 8401
Spital Zollikerberg
Zollikerberg, 8125
Uniklinik Balgrist
Zurich, 8008
About this study
The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration.
For the purpose effectiveness is defined in two ways.1) as a reduction in hospital readmissions for complication for foot ulcers such as amputation or increased severity of the ulcer and 2) reduction in amputations, readmission rates. Selected covariates (self-efficacy,self-management, social support and depression) will be included to estimate predictors for readmission and 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.
Currently, the standard of care includes admissions to the hospital lasting up to six weeks for medical observations and treatment of food ulcers.
The nursing responsibilities include daily or more frequent wound care as well as education counselling and skill building for diabetes self-management; therefore, an alternative to current practices must be considered. Such an alternative strategy has the potential benefit for the patient as well as the societal benefit of economic savings should such an outpatient nurse managed intervention be as or more effective as current practice. This type of service would allow the patients to remain in their home for care with probably a reduced risk for nosocomial infections.
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. We plan to determine whether foot ulcer care in hospital under medical and nursing management can be improved by early discharge of the Intervention group (IG) to the well established outpatient wound care combined with an additional new outpatient nurse managed counselling program.
Expected results:
This 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.
Also, patients in the hospital are in danger of acquiring nosocomial infections, are subject to medical and nursing errors and are potentially accident prone; all of this together with a general preference for being able to live at home as compared to the hospital, together with the cost savings mentioned above could have a considerable impact on patient's quality of life, satisfaction with care, improvement in food ulcer and amputation outcomes.
Significance:
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
- Nursing counseling, diabetic foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing counselingBehavioural
The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received 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 received three specially-developed brochures with information regarding the diabetic foot condition. The brochures contained 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. The participants who were randomized in the control group received standard care. Standard care consisted of either physician-prescribed inpatient or outpatient wound care. |
| Nursing counseling | Experimental | Not described Receives: Behavioral: Nursing counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of an intensive nurse led education program
Recruitment procedures feasible yes/no; Randomization procedure feasible yes/no; Timeframe of the five week educational program feasible yes/no; Intervention material suitable yes/no
Measured: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Kantonsspital Frauenfeld, Spital Zollikerberg
- Responsible party
- Principal investigator, Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731808
- Sponsor's protocol ID
- 2010-0278/0
- Status last verified
- Mar 2014
- First submitted
- 18 Oct 2012
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. 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: a Pilot Study
- ClinicalTrials.gov ID
- NCT01731808
- Acronym / sponsor ID
- 2010-0278/0
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Nursing counseling, diabetic foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Balgrist University Hospital, Kantonsspital Winterthur KSW, Luzerner Kantonsspital, Kantonsspital Frauenfeld, Spital Zollikerberg
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Nov 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.
The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration.
For the purpose effectiveness is defined in two ways.1) as a reduction in hospital readmissions for complication for foot ulcers such as amputation or increased severity of the ulcer and 2) reduction in amputations, readmission rates. Selected covariates (self-efficacy,self-management, social support and depression) will be included to estimate predictors for readmission and 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.
Currently, the standard of care includes admissions to the hospital lasting up to six weeks for medical observations and treatment of food ulcers.
The nursing responsibilities include daily or more frequent wound care as well as education counselling and skill building for diabetes self-management; therefore, an alternative to current practices must be considered. Such an alternative strategy has the potential benefit for the patient as well as the societal benefit of economic savings should such an outpatient nurse managed intervention be as or more effective as current practice. This type of service would allow the patients to remain in their home for care with probably a reduced risk for nosocomial infections.
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. We plan to determine whether foot ulcer care in hospital under medical and nursing management can be improved by early discharge of the Intervention group (IG) to the well established outpatient wound care combined with an additional new outpatient nurse managed counselling program.
Expected results:
This 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.
Also, patients in the hospital are in danger of acquiring nosocomial infections, are subject to medical and nursing errors and are potentially accident prone; all of this together with a general preference for being able to live at home as compared to the hospital, together with the cost savings mentioned above could have a considerable impact on patient's quality of life, satisfaction with care, improvement in food ulcer and amputation outcomes.
Significance:
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –All participants received three specially-developed brochures with information regarding the diabetic foot condition. The brochures contained 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. The participants who were randomized in the control group received standard care. Standard care consisted of either physician-prescribed inpatient or outpatient wound care. |
| Nursing counseling | Experimental | Behavioral: Nursing counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients age 18 or older with
- current treatment for ulceration and/or amputation of a lower limb
- stable wound healing
- no signs of wound infection
- stable diabetes
Key exclusion criteria (2 listed)
- patients with cognitive impairment and psychiatric diseases
- patients living in dependent living facilities
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 were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary. | Behavioural | Nursing counseling |
Primary outcome
feasibility of an intensive nurse led education program
Time frame: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.
Recruitment procedures feasible yes/no; Randomization procedure feasible yes/no; Timeframe of the five week educational program feasible yes/no; Intervention material suitable yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 5 sites 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
feasibility of an intensive nurse led education program (time frame: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.). 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 4 Mar 2014.