Clinical trial NCT02228629: Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
Official title: Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Foot complications
plantar keratoma
plantar pressure
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
timeFrame: At visit 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gait Study Center at the Temple University School of Podiatric Medicine
state: Pennsylvania
Study officials:
References: