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Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02102958
Enrollment
57
Registered
2014-04-03
Start date
2011-07-31
Completion date
2013-12-31
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Visual Impairment

Keywords

diabetes, visual impairment, foot care, diabetes self-management education

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).

Interventions

BEHAVIORALDSME 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.

BEHAVIORALDSME 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.

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of foot examination at home6 monthsnumber of times that the enrolled participant or someone else examined the person's feet at home during the study period

Secondary

MeasureTime frameDescription
New foot problems discovered at home6 monthstotal 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

MeasureTime frameDescription
Total new foot problems6 monthstotal number of foot problems documented by the podiatrist at podiatry visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026