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OpenTrials
Completed

NCT Number: NCT02102958

Nonvisual Foot Examination for People With Diabetes and Visual Impairment

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DSME with Nonvisual Foot Examination

Behavioral

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.

DSME with Usual Foot Examination Instruction

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Total new foot problems

    Time frame: 6 months

    total number of foot problems documented by the podiatrist at podiatry visit

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2014
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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