NCT02086955

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

March 3, 2014

Last Update Submit

January 23, 2015

Conditions

Diabetic Foot Ulcer

Keywords

DiabetesNursing counselingFoot ulcerationOutpatientAdvanced Practice Nurse

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (2)

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.

Behavioral: Nursing counseling

Interventions

Nursing counselingBEHAVIORAL

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.

Nursing counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Study Officials

  • Lorenz Imhof, Prof. Dr.

    University of applied sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Imhof, Prof. Dr.

CONTACT

0041589346333lorenz.imhof@zhaw.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 13, 2014

Study Start

February 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

CH(1)