Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

January 23, 2015 updated by: Prof. Dr. Lorenz Imhof, Zurich University of Applied Sciences

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Zurich
      • Winterthur, Zurich, Switzerland, 8400
        • Recruiting
        • Zurich University of Applied Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
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.
Experimental: Nursing counseling
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.
Behavioral: Nursing counseling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurich University of Applied Sciences

Collaborators

Swiss National Science Foundation
Nursing Science Foundation Switzerland

Investigators

  • Principal Investigator: Lorenz Imhof, Prof. Dr., University of applied sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 320030_143863
  • 2010-0278/0 (Other Identifier: KEK-ZH-NR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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