Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
Status unconfirmed · Not applicable
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT02228629
- Run by
- Temple University
- People needed
- 45
- Starts
- 2014-10-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2015-05-13
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Gait Study Center at the Temple University School of Podiatric Medicine — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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