Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | October 2014 |
| End Date: | October 2015 |
| Contact: | Jinsup Song |
| Email: | jsong@temple.edu |
| Phone: | 215-625-5369 |
Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
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.
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.
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
We found this trial at
1
site
927 West Berks Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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