CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 381 enrolled
Drug / intervention
Standard therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01221194
NCT01221194N/ACompleted
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Therapeutic Stockings to Prevent Foot Ulcers

University of Texas Southwestern Medical Center·interventional·Posted Oct 14, 2010·Updated Aug 26, 2020

In Brief

A clinical study evaluating Standard therapy and PFC Stockings for Diabetes. Completed, enrolled 381 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited Kingdom, United States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2010
Enrollment StartOct 1, 2010
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.7 years ago

Interventions

Standard therapybehavioral

Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.

PFC Stockingsdevice

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.