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

Diabetes Clinical Trial

Official title:

Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228629
• Other study ID #: 21391
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2014
• Last updated: May 12, 2015
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: Temple University
• Contact: Jinsup Song
• Phone: 215-625-5369
• Email: jsong[@]temple.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• CrocsRx Medical Silver cloud clogs

Locations

Country	Name	City	State
United States	Gait Study Center at the Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs	In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.	At visit 1.	No