Therapeutic Stockings to Prevent Foot Ulcers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard therapy

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

PFC Stockings

Intervention Type DEVICE

A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.

Interventions

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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.

Intervention Type BEHAVIORAL

PFC Stockings

A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No