Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Diabetes Clinical Trial

Official title:

Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102958
• Other study ID #: R21NR012513
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• DSME 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.
• DSME 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.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total new foot problems	total number of foot problems documented by the podiatrist at podiatry visit	6 months
Primary	Frequency of foot examination at home	number of times that the enrolled participant or someone else examined the person's feet at home during the study period	6 months
Secondary	New foot problems discovered at home	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	6 months