Therapeutic Stockings to Prevent Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Standard therapy; Device: PFC Stockings

• Registration Number: NCT01221194
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

1. 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.

2. 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2020-08
• Results First Submitted: 2020-08-12
• Results First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Results First Posted: 2020-08-26
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

Inclusion Criteria

• Men or women 18 years old or older
• Diagnosis of Diabetes Mellitus*
• History of diabetes related foot ulceration

Spanish-speaking subjects will be eligible to participate.

Exclusion Criteria

• Active Charcot Arthropathy
• Gangrene, active infection
• Midfoot or higher level amputation
• Alcohol or substance abuse within 6 months
• Unreliable, unwilling or unable to comprehend informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy	Standard therapy	Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
PFC Stockings	PFC Stockings	The stocking therapy group will be given PFC shear reducing stockings to wear.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Foot Ulcer During Study Time Frame	30 months	An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.

Trial Locations

Locations (4)

Parkland Health & Hospital Systems; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

University of Manchester; 🇬🇧 Manchester, United Kingdom

Scott & White; 🇺🇸 Temple, Texas, United States