DiabetesNCT01822717
Nonvisual Foot Inspection for People With Visual Impairment
A study testing Nonvisual foot inspection in people with Diabetes and Visual Impairment, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Visual Impairment
- What is being tested?
- Nonvisual foot inspection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18
- Diagnosed with diabetes (either type 1 or type 2)
- Having visual impairment
Who cannot join
- Self-reported numbness in hands
- Inability to pass a brief screening for decisional capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Foot and Ankle Institute
Cleveland, Ohio, 44103
About this study
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.
Read the 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
- Conditions
- Diabetes, Visual Impairment
- Being tested
- Nonvisual foot inspection, Usual Care
- Keywords
- Diabetes, Visual Impairment, Blindness, Foot Care, Self-Management
- Medical subject headings
- Diabetes Mellitus, Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonvisual foot inspectionBehavioural
Also called Multi-SAFE (Multiple Senses And Foot Examination)
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 CareBehavioural
Also called Standard foot care instructions
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
| Study group | Role | What they receive |
|---|---|---|
| Nonvisual foot inspection | Experimental | Instruction for nonvisual foot inspection included in comprehensive diabetes self-management education Receives: Behavioral: Nonvisual foot inspection |
| Usual Care for foot inspection | Active comparator | Usual instruction for foot care included in comprehensive diabetes self-management education Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: every 2 months for 1 year
Secondary outcomes (1)
Number of foot problems discovered
Number of foot problems discovered by podiatrists or at home by participants
Measured: every 3 months for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Kent State University
- Responsible party
- Sponsor
- Investigators
- Ann S Williams, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822717
- Sponsor's protocol ID
- BRIDGES- ST09 49
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonvisual Foot Inspection for People With Visual Impairment
- ClinicalTrials.gov ID
- NCT01822717
- Acronym / sponsor ID
- BRIDGES- ST09 49
- Conditions
- Diabetes, Visual Impairment
- Keywords
- Diabetes, Visual Impairment, Blindness, Foot Care, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Kent State University
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonvisual foot inspection | Experimental | Behavioral: Nonvisual foot inspectionInstruction for nonvisual foot inspection included in comprehensive diabetes self-management education |
| Usual Care for foot inspection | Active comparator | Behavioral: Usual CareUsual instruction for foot care included in comprehensive diabetes self-management education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over age 18
- Diagnosed with diabetes (either type 1 or type 2)
- Having visual impairment
Key exclusion criteria (2 listed)
- Self-reported numbness in hands
- Inability to pass a brief screening for decisional capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonvisual foot inspectionAlso: Multi-SAFE (Multiple Senses And Foot Examination)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 | Behavioural | Nonvisual foot inspection |
| Usual CareAlso: Standard foot care instructionsStandard 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 | Behavioural | Usual Care for foot inspection |
Primary outcome
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)
1 secondary outcome
Number of foot problems discovered
Time frame: every 3 months for 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- BackgroundWilliams 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann S Williams, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonvisual foot inspection in people with Diabetes and Visual Impairment, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days per week participants performed foot inspection (time frame: every 2 months for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.