Clincosm LogoSign in Get a demo

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

Sponsor
Temple University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02228629
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
12
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CrocsRx Medical Silver cloud clogs
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
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?
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2015
Anticipated Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Typical house shoe

Subject's typical shoes worn in and around home

Device: CrocsRx Medical Silver cloud clogs

Outcome Measures

Primary Outcome Measures

  1. Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
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

Locations

Site City State Country Postal Code
1 Gait Study Center at the Temple University School of Podiatric Medicine Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Temple University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jinsup Song, Director, Gait Study Center, Temple University
ClinicalTrials.gov Identifier:
NCT02228629
Other Study ID Numbers:
  • 21391
First Posted:
Aug 29, 2014
Last Update Posted:
May 13, 2015
Last Verified:
May 1, 2015
Keywords provided by Jinsup Song, Director, Gait Study Center, Temple University
Diabetes
Foot complications
plantar keratoma
plantar pressure
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of May 13, 2015