- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822717
Nonvisual Foot Inspection for People With Visual Imapirment
March 28, 2013 updated by: Ann S. Williams, Case Western Reserve University
Nonvisual Foot Inspection for People With Visual Impairment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44103
- Cleveland Foot and Ankle Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nonvisual foot inspection
Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education
|
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
Other Names:
|
Active Comparator: Usual Care for foot inspection
Usual instruction for foot care included in comprehensive diabetes self-management education
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days per week participants performed foot inspection
Time Frame: every 2 months for 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of foot problems discovered
Time Frame: every 3 months for 1 year
|
Number of foot problems discovered by podiatrists or at home by participants
|
every 3 months for 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: 1 year
|
Qualitative information from focus groups
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann S Williams, PhD, Case Western Reserve University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
March 28, 2013
First Posted (Estimate)
April 2, 2013
Study Record Updates
Last Update Posted (Estimate)
April 2, 2013
Last Update Submitted That Met QC Criteria
March 28, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRIDGES- ST09 49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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