Status:
COMPLETED
Therapeutic Stockings to Prevent Foot Ulcers
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 hea...
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 Roya...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT01221194
Start Date
October 1 2010
End Date
March 1 2016
Last Update
August 26 2020
Active Locations (4)
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1
Parkland Health & Hospital Systems
Dallas, Texas, United States, 75235
2
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
3
Scott & White
Temple, Texas, United States, 76502
4
University of Manchester
Manchester, United Kingdom