Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01221194
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2010-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Stockings to Prevent Foot Ulcers
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Therapeutic Stockings to Prevent Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.
2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: