Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

Diabetic Foot Ulcer Clinical Trial

Official title:

Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086955
• Other study ID #: 320030_143863
• Secondary ID: 2010-0278/0
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2014
• Last updated: January 23, 2015
• Start date: February 2013
• Est. completion date: February 2016

Study information

• Verified date: January 2015
• Source: Zurich University of Applied Sciences
• Contact: Lorenz Imhof, Prof. Dr.
• Phone: 0041589346333
• Email: lorenz.imhof[@]zhaw.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethic committee / Laws and standards
• Study type: Interventional

Clinical 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) 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Zurich University of Applied Sciences	Winterthur	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences	Nursing Science Foundation Switzerland, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).	No

External Links

•   Project Website