Therapeutic Stockings to Prevent Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Stockings to Prevent Foot Ulcers

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Standard therapy
* Device: PFC Stockings


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard therapy<br>Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. | Behavioral: Standard therapy<br>* Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.<br>|
| Active Comparator: PFC Stockings<br>The stocking therapy group will be given PFC shear reducing stockings to wear. | Device: PFC Stockings<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, foot ulcer prevention, therapeutic stockings