DiabetesNCT02228629
Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
A study testing CrocsRx Medical Silver cloud clogs in people with Diabetes, run by Temple University at 1 site in United States.
Trial summary
Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- CrocsRx Medical Silver cloud clogs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2015
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 21 and 75 (inclusive)
- Documented type 1 or type 2 diabetes mellitus
- Demonstrated abnormal foot biomechanics by the presence of intractable plantar keratoma (IPK) beneath metatarsal heads or hallux
- Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT > 25 Volts)
- Able to walk independently without the use of walking aids (cane, crutches, or walker)
- Able to speak and understand English
- Able to understand the information in the consent form and willing and able to sign the consent form
Who cannot join
- History of lower limb amputations (excluding toe amputations)
- Presence of cutaneous ulceration in the lower extremity
- History of or active Charcot neuroarthropathy of either foot
- Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene)
- End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
- Pregnant or nursing
Show all 9Show fewer
- Not willing or able to make the required follow-up visits
- Insufficient (corrected) vision to complete the questionnaire
- Unable to fit into available shoe sizes
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gait Study Center at the Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Jinsup Song, D.P.M., Ph.D., 215-625-5369, jsong@temple.edu
Jinsup Song, D.P.M., Ph.D.
About this study
Official title: Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such as flip flops or slippers, that provide little to no protection against injuries. While proper house shoe is important in the prevention of diabetic foot complications, this area has not received much attention. The purpose of this pilot study is to assess if CrocsRx Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles, and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with the order of shoes randomized.
- Conditions
- Diabetes
- Being tested
- CrocsRx Medical Silver cloud clogs
- Keywords
- Diabetes, Foot complications, plantar keratoma, plantar pressure
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrocsRx Medical Silver cloud clogsDevice
| Study group | Role | What they receive |
|---|---|---|
| Typical house shoe | Experimental | Subject's typical shoes worn in and around home Receives: Device: CrocsRx Medical Silver cloud clogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.
Measured: At visit 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsup Song, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228629
- Sponsor's protocol ID
- 21391
- Status last verified
- May 2015
- First submitted
- 27 Aug 2014
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
- ClinicalTrials.gov ID
- NCT02228629
- Acronym / sponsor ID
- 21391
- Conditions
- Diabetes
- Keywords
- Diabetes, Foot complications, plantar keratoma, plantar pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 29 Aug 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.
Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such as flip flops or slippers, that provide little to no protection against injuries. While proper house shoe is important in the prevention of diabetic foot complications, this area has not received much attention. The purpose of this pilot study is to assess if CrocsRx Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles, and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with the order of shoes randomized.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Typical house shoe | Experimental | Device: CrocsRx Medical Silver cloud clogsSubject's typical shoes worn in and around home |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between the ages of 21 and 75 (inclusive)
- Documented type 1 or type 2 diabetes mellitus
- Demonstrated abnormal foot biomechanics by the presence of intractable plantar keratoma (IPK) beneath metatarsal heads or hallux
- Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT > 25 Volts)
- Able to walk independently without the use of walking aids (cane, crutches, or walker)
Key exclusion criteria (9 listed)
- History of lower limb amputations (excluding toe amputations)
- Presence of cutaneous ulceration in the lower extremity
- History of or active Charcot neuroarthropathy of either foot
- Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene)
- End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
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 |
|---|---|---|
| CrocsRx Medical Silver cloud clogs | Device | Typical house shoe |
Primary outcome
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
Time frame: At visit 1.
In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CrocsRx Medical Silver cloud clogs in people with Diabetes, run by Temple 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsup Song (215-625-5369, jsong@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs (time frame: At visit 1.). 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 13 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.