DiabetesNCT02102958
Nonvisual Foot Examination for People With Diabetes and Visual Impairment
A study testing DSME with Nonvisual Foot Examination and DSME with Usual Foot Examination Instruction in people with Diabetes and Visual Impairment, run by Case Western Reserve University at 1 site in United States.
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… 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?
- DSME with Nonvisual Foot Examination and DSME with Usual Foot Examination Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2013
- 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 either type 1 or type 2 diabetes
- stated they had visual impairment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
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).
- Conditions
- Diabetes, Visual Impairment
- Being tested
- DSME with Nonvisual Foot Examination, DSME with Usual Foot Examination Instruction
- Keywords
- diabetes, visual impairment, foot care, diabetes self-management education
- Medical subject headings
- Diabetes Mellitus, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSME with Nonvisual Foot ExaminationBehavioural
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 InstructionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | DSME with Nonvisual Foot Examination Receives: Behavioral: DSME with Nonvisual Foot Examination |
| Comparison | Active comparator | DSME with Usual Foot Examination Instruction Receives: Behavioral: DSME with Usual Foot Examination Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann S Williams, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102958
- Sponsor's protocol ID
- R21NR012513
- Status last verified
- Mar 2014
- First submitted
- 31 Mar 2014
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonvisual Foot Examination for People With Diabetes and Visual Impairment
- ClinicalTrials.gov ID
- NCT02102958
- Acronym / sponsor ID
- R21NR012513
- Conditions
- Diabetes, Visual Impairment
- Keywords
- diabetes, visual impairment, foot care, diabetes self-management education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Apr 2014 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: DSME with Nonvisual Foot ExaminationDSME with Nonvisual Foot Examination |
| Comparison | Active comparator | Behavioral: DSME with Usual Foot Examination InstructionDSME with Usual Foot Examination Instruction |
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 either type 1 or type 2 diabetes
- stated they had visual impairment
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| DSME with Nonvisual Foot ExaminationDiabetes 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. | Behavioural | Experimental |
| DSME with Usual Foot Examination InstructionDSME 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. | Behavioural | Comparison |
Primary outcome
Frequency of foot examination at home
Time frame: 6 months
number of times that the enrolled participant or someone else examined the person's feet at home during the study period
1 secondary outcome
New foot problems discovered at home
Time frame: 6 months
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 14 Nov 2023.
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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 DSME with Nonvisual Foot Examination and DSME with Usual Foot Examination Instruction 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 4 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 14 Nov 2023. 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?
Frequency of foot examination at home (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2023.