Therapeutic Stockings to Prevent Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Standard therapy; Device: 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 Type: Interventional
• Enrollment (Actual): 381
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • University of Manchester
• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas
    • Dallas, Texas, United States, 75235
      • Parkland Health & Hospital Systems
    • Temple, Texas, United States, 76502
      • Scott & White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: 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.
ACTIVE_COMPARATOR: PFC Stockings; The stocking therapy group will be given PFC shear reducing stockings to wear.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (ESTIMATE): October 14, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; foot ulcer prevention; therapeutic stockings
• Additional Relevant MeSH Terms: Skin Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer
• Other Study ID Numbers: STU 082010-090

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes