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Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study

NCT01731808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-03-04

No results posted yet for this study

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.

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

BEHAVIORAL

Nursing counseling

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.

Sponsors & Collaborators

  • Balgrist University Hospital

    collaborator OTHER

  • Kantonsspital Winterthur KSW

    collaborator OTHER

  • Luzerner Kantonsspital

    collaborator OTHER

  • Kantonsspital Frauenfeld

    collaborator OTHER

  • Spital Zollikerberg

    collaborator OTHER

  • Zurich University of Applied Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731808 on ClinicalTrials.gov