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Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Case Western Reserve University logo

Case Western Reserve University

Status

Completed

Conditions

Diabetes
Visual Impairment

Treatments

Behavioral: DSME with Nonvisual Foot Examination
Behavioral: DSME with Usual Foot Examination Instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02102958
R21NR012513

Details and patient eligibility

About

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).

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups

Experimental
Experimental group
Description:
DSME with Nonvisual Foot Examination
Treatment:
Behavioral: DSME with Nonvisual Foot Examination
Comparison
Active Comparator group
Description:
DSME with Usual Foot Examination Instruction
Treatment:
Behavioral: DSME with Usual Foot Examination Instruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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