Therapeutic Stockings to Prevent Foot Ulcers

Diabetes Clinical Trial

Official title:

Therapeutic Stockings to Prevent Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221194
• Other study ID #: STU 082010-090
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: March 2016

Study information

• Verified date: August 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Foot Ulcer

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester
United States	Parkland Health & Hospital Systems	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Scott & White	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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