Nonvisual Foot Inspection for People With Visual Imapirment

March 28, 2013 updated by: Ann S. Williams, Case Western Reserve University

Nonvisual Foot Inspection for People With Visual Impairment

The purpose of this study was to find out whether a method of nonvisual foot inspection, using the senses of touch and smell, helps people with diabetes and visual impairment to find new foot problems when they are in early, easily-treated stages. All people in the study had regular foot inspections by podiatrists. The results include how people feel about the method, whether they actually did check their feet it, and whether the method helped them to discover foot problems themselves.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data gathered over the course of 1 year:

  • bimonthly phone calls to ask about foot care practices at home over the last week
  • a baseline comprehensive foot evaluation and 4 additional comprehensive evaluations every 3 months

Qualitative data:

- Focus groups immediately after comprehensive diabetes self-management education, and 1 year later, to determine acceptability of foot care procedures and patient perceptions about effectiveness

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44103
        • Cleveland Foot and Ankle Institute

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:

  • Over age 18
  • Diagnosed with diabetes (either type 1 or type 2)
  • Having visual impairment

Exclusion Criteria:

  • Self-reported numbness in hands
  • Inability to pass a brief screening for decisional capacity

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nonvisual foot inspection
Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education
Behavioral: Nonvisual foot inspection
Teaching use of nonvisual senses (tactile and olfactory) to empower people with diabetes and visual impairment to perform a systematic self-examination of their own feet
Other Names:
  • Multi-SAFE (Multiple Senses And Foot Examination)
Active Comparator: Usual Care for foot inspection
Usual instruction for foot care included in comprehensive diabetes self-management education
Behavioral: Usual Care
Standard instructions for foot care for people with visual impairment include advice to have a sighted family member or friend check the person's feet regularly
Other Names:
  • Standard foot care instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days per week participants performed foot inspection
Time Frame: every 2 months for 1 year
Number of days in the last week each participants reported checking their feet for problems, using nonvisual methods (experimental group) or with assistance form someone else (comparison group)
every 2 months for 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of foot problems discovered
Time Frame: every 3 months for 1 year
Number of foot problems discovered by podiatrists or at home by participants
every 3 months for 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 1 year
Qualitative information from focus groups
1 year

Collaborators and Investigators

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

Sponsor

Case Western Reserve University

Collaborators

Kent State University

Investigators

  • Principal Investigator: Ann S Williams, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Williams A. Appraising the Multi-SAFE approach to low vision and diabetes: a simple technique for saving feet. Diabetes Voice 56(Special Issue 1):14-17, 2011

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

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIDGES- ST09 49

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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