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OpenTrials
Completed

NCT Number: NCT01822717

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.

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Key information

Conditions

Diabetes Blindness 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

Cleveland Foot and Ankle Institute

Cleveland, Ohio, 44103, United States

About this study

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

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 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

Treatment and study plan

Nonvisual foot inspection

Behavioral

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)

Usual Care

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Other outcomes

  1. Acceptability

    Time frame: 1 year

    Qualitative information from focus groups

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Kent State University

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2013
Registry last updated
Sep 19, 2024

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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