Recruiting

CrocsRx Clog

Sponsor:

Temple University

Code:

NCT02228629

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

CrocsRx Medical Silver cloud clogs

Study Details

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.

Conditions

Diabetes

Study ID

NCT02228629

Start date

Oct, 2014

Status verified date

May, 2015

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Typical house shoe

Subject's typical shoes worn in and around home

Interventions

CrocsRx Medical Silver cloud clogs

Primary outcome measure

  • Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs [ Time Frame: At visit 1. ]

Central Contacts and Locations

Central contacts

Jinsup Song

215-625-5369jsong@temple.edu

Locations

Gait Study Center at the Temple University School of Podiatric Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Jinsup Song, D.P.M., Ph.D.

215-625-5369jsong@temple.edu

Principal Investigator:

Jinsup Song, D.P.M., Ph.D.

More Information

Sponsor

Temple University

Last update posted

May 13, 2015

Last verified

May, 2015

Keywords

  • Diabetes
  • Foot complications
  • plantar keratoma
  • plantar pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2015-05-13.