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

NCT01731808 | Completed DMC

• 1 other identifier: 2010-0278/0
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Nursing counseling; diabetic foot

Outcome Measures

Primary Outcomes (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

  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.

Study Arms (2)

Standard care

NO INTERVENTION

All 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 counseling

EXPERIMENTAL

Behavioral: Nursing counseling

Interventions

Nursing counseling BEHAVIORAL

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.

Nursing counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with cognitive impairment and psychiatric diseases
• patients living in dependent living facilities

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead
• Balgrist University Hospital: collaborator
• Kantonsspital Winterthur KSW: collaborator
• Luzerner Kantonsspital: collaborator
• Kantonsspital Frauenfeld: collaborator
• Spital Zollikerberg: collaborator

Study Sites (5)

Kantonsspital Frauenfeld

Frauenfeld, 8501, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Spital Zollikerberg

Zollikerberg, 8125, Switzerland

Location

Uniklinik Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

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

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: November 22, 2012
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

CH (5)