Nonvisual Foot Inspection for People With Visual Imapirment

Diabetes Clinical Trial

Official title:

Nonvisual Foot Inspection for People With Visual Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822717
• Other study ID #: BRIDGES- ST09 49
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: March 28, 2013
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Visual Impairment

Intervention

Behavioral:
• Nonvisual foot inspection
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
• Usual Care
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

Locations

Country	Name	City	State
United States	Cleveland Foot and Ankle Institute	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	Kent State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Williams A. Appraising the Multi-SAFE approach to low vision and diabetes: a simple technique for saving feet. Diabetes Voice 56(Special Issue 1):14-17, 2011

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability	Qualitative information from focus groups	1 year	No
Primary	Days per week participants performed foot inspection	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)	every 2 months for 1 year	Yes
Secondary	Number of foot problems discovered	Number of foot problems discovered by podiatrists or at home by participants	every 3 months for 1 year	Yes