Nonvisual Foot Inspection for People With Visual Impairment
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedSeptember 19, 2024
September 1, 2024
2 years
March 28, 2013
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of foot problems discovered
every 3 months for 1 year
Other Outcomes (1)
Acceptability
1 year
Study Arms (2)
Nonvisual foot inspection
EXPERIMENTALInstruction for nonvisual foot inspection included in comprehensive diabetes self-management education
Usual Care for foot inspection
ACTIVE COMPARATORUsual instruction for foot care included in comprehensive diabetes self-management education
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Over age 18
- Diagnosed with diabetes (either type 1 or type 2)
- Having visual impairment
You may not qualify if:
- Self-reported numbness in hands
- Inability to pass a brief screening for decisional capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- Kent State Universitycollaborator
Study Sites (1)
Cleveland Foot and Ankle Institute
Cleveland, Ohio, 44103, United States
Related 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann S Williams, PhD
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 2, 2013
Study Start
September 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 19, 2024
Record last verified: 2024-09