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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Switzerland

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.

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 groups in NCT01731808
Study groupRoleWhat they receive
Standard careNo interventionAll 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 counselingExperimentalNot described
Receives: Behavioral: Nursing counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted22 Nov 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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)
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

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.

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