Nonvisual Foot Examination for People With Diabetes and Visual Impairment

November 10, 2023 updated by: Case Western Reserve University
Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

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, 44106
        • Case Western Reserve University

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

Description

Inclusion Criteria:

  • over age 18
  • diagnosed with either type 1 or type 2 diabetes
  • stated they had visual impairment

Exclusion Criteria:

  • unable to pass a brief decisional capacity test
  • had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire
  • had bilateral lower extremity amputations
  • by self-report were unable to sense light touch on two or more fingers or either hand

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
DSME with Nonvisual Foot Examination
Behavioral: DSME with Nonvisual Foot Examination
Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.
Active Comparator: Comparison
DSME with Usual Foot Examination Instruction
Behavioral: DSME with Usual Foot Examination Instruction
DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of foot examination at home
Time Frame: 6 months
number of times that the enrolled participant or someone else examined the person's feet at home during the study period
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New foot problems discovered at home
Time Frame: 6 months
total number of new foot problems reported to podiatrists as having been discovered at home by the participant or someone else examining the person's feet
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total new foot problems
Time Frame: 6 months
total number of foot problems documented by the podiatrist at podiatry visit
6 months

Collaborators and Investigators

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

Sponsor

Case Western Reserve University

Investigators

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

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

July 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimated)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21NR012513 (U.S. NIH Grant/Contract)

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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