Status:
UNKNOWN
Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
Lead Sponsor:
Temple University
Conditions:
Diabetes
Eligibility:
All Genders
21-75 years
Phase:
NA
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 sh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02228629
Start Date
October 1 2014
End Date
October 1 2015
Last Update
May 13 2015
Active Locations (1)
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1
Gait Study Center at the Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107