Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Not Applicable

Completed

• Conditions: Diabetes; Visual Impairment
• Interventions: Behavioral: DSME with Usual Foot Examination Instruction; Behavioral: DSME with Nonvisual Foot Examination

• Registration Number: NCT02102958
• Lead Sponsor: Case Western Reserve University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison	DSME with Usual Foot Examination Instruction	DSME with Usual Foot Examination Instruction
Experimental	DSME with Nonvisual Foot Examination	DSME with Nonvisual Foot Examination

Primary Outcome Measures

Name	Time	Method
Frequency of foot examination at home	6 months	number of times that the enrolled participant or someone else examined the person's feet at home during the study period

Secondary Outcome Measures

Name	Time	Method
New foot problems discovered at home	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

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States