Therapeutic Stockings to Prevent Foot Ulcers

University of Texas Southwestern Medical Center4 sites in 2 countries381 target enrollmentOctober 2010

ConditionsDiabetes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 381
Locations: 4
Primary Endpoint: Number of Participants Who Developed Foot Ulcer During Study Time Frame
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

Detailed Description

We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

March 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel