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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Jinsup Song, Temple University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jinsup Song, Temple University Identifier:
First received: August 27, 2014
Last updated: May 12, 2015
Last verified: May 2015
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.

Condition Intervention
Diabetes Device: CrocsRx Medical Silver cloud clogs

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?

Further study details as provided by Jinsup Song, Temple University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 45
Study Start Date: October 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Typical house shoe
Subject's typical shoes worn in and around home
Device: CrocsRx Medical Silver cloud clogs


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02228629

Contact: Jinsup Song 215-625-5369

United States, Pennsylvania
Gait Study Center at the Temple University School of Podiatric Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jinsup Song, D.P.M., Ph.D.    215-625-5369   
Principal Investigator: Jinsup Song, D.P.M., Ph.D.         
Sponsors and Collaborators
Temple University
  More Information

Responsible Party: Jinsup Song, Director, Gait Study Center, Temple University Identifier: NCT02228629     History of Changes
Other Study ID Numbers: 21391
Study First Received: August 27, 2014
Last Updated: May 12, 2015

Keywords provided by Jinsup Song, Temple University:
Foot complications
plantar keratoma
plantar pressure processed this record on August 18, 2017