Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?

Conditions
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Diabetes

Intervention / Treatment
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* Device: CrocsRx Medical Silver cloud clogs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Typical house shoe<br>Subject's typical shoes worn in and around home | Device: CrocsRx Medical Silver cloud clogs<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At visit 1. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Foot complications, plantar keratoma, plantar pressure