CClinicalTrials.gg
Status unknownNCT02228629Updated May 13, 2015

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

An interventional study of CrocsRx Medical Silver cloud clogs in Diabetes, sponsored by Temple University. Status unknown at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by Temple University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

Browse trials for

Keywords

  • Diabetes
  • Foot complications
  • plantar keratoma
  • plantar pressure
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 45 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Typical house shoe

    Subject's typical shoes worn in and around home

    Device: CrocsRx Medical Silver cloud clogs

Interventions

  • DeviceCrocsRx Medical Silver cloud clogs
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At visit 1.

07

Study locations

1 of 1 sites recruiting
  • Gait Study Center at the Temple University School of Podiatric Medicine
    Philadelphia, Pennsylvania 19107, United States
    • Jinsup Song, D.P.M., Ph.D. · Contact · jsong@temple.edu · 215-625-5369
    • Jinsup Song, D.P.M., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02228629
Lead sponsor
Temple University
Responsible party
Jinsup Song (Director, Gait Study Center, Temple University) — Principal investigator
First posted
Aug 29, 2014
Start date
Oct 2014
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
May 13, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion