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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Temple University
Sponsor:
Information provided by (Responsible Party):
Jinsup Song, Temple University
ClinicalTrials.gov Identifier:
NCT02228629
First received: August 27, 2014
Last updated: August 28, 2014
Last verified: March 2014
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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 Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02228629

Contacts
Contact: Jinsup Song 215-625-5369 jsong@temple.edu

Locations
United States, Pennsylvania
Gait Study Center at the Temple University School of Podiatric Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jinsup Song, D.P.M., Ph.D.    215-625-5369    jsong@temple.edu   
Principal Investigator: Jinsup Song, D.P.M., Ph.D.         
Sponsors and Collaborators
Temple University
  More Information

No publications provided

Responsible Party: Jinsup Song, Director, Gait Study Center, Temple University
ClinicalTrials.gov Identifier: NCT02228629     History of Changes
Other Study ID Numbers: 21391
Study First Received: August 27, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Temple University:
Diabetes
Foot complications
plantar keratoma
plantar pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014