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

NCT ID: NCT02228629

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-10-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Typical house shoe

Subject's typical shoes worn in and around home

Group Type: EXPERIMENTAL

CrocsRx Medical Silver cloud clogs

Intervention Type: DEVICE

Interventions

CrocsRx Medical Silver cloud clogs

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Jinsup Song

Director, Gait Study Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gait Study Center at the Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jinsup Song

Role: CONTACT

jsong@temple.edu

215-625-5369

Facility Contacts

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

Role: primary

jsong@temple.edu

215-625-5369

Other Identifiers

21391

Identifier Type: -

Identifier Source: org_study_id