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

Temple University

Status

Unknown

Conditions

Diabetes

Treatments

Device: CrocsRx Medical Silver cloud clogs

Study type

Interventional

Funder types

Other

Identifiers

NCT02228629

21391

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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