Therapeutic Stockings to Prevent Foot Ulcers

The University of Texas System (UT)

Status: Completed

Conditions: Diabetes

Treatments: Device: PFC Stockings; Behavioral: Standard therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01221194

STU 082010-090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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381 participants in 2 patient groups

Standard therapy

Active Comparator group

Description:

Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.

Treatment:

Behavioral: Standard therapy

PFC Stockings

Active Comparator group

Description:

The stocking therapy group will be given PFC shear reducing stockings to wear.

Treatment:

Device: PFC Stockings