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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02228629
Recruitment Status : Unknown
Verified May 2015 by Jinsup Song, Temple University.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Jinsup Song, Temple University

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE August 29, 2014
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs [ Time Frame: At visit 1. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02228629 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
Official Title  ICMJE Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes
Intervention  ICMJE Device: CrocsRx Medical Silver cloud clogs
Study Arms  ICMJE Experimental: Typical house shoe
Subject's typical shoes worn in and around home
Intervention: Device: CrocsRx Medical Silver cloud clogs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02228629
Other Study ID Numbers  ICMJE 21391
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinsup Song, Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Temple University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP