N/A N=381 Randomized Single-blind Prevention

Therapeutic Stockings to Prevent Foot Ulcers

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01221194 ↗

Enrolled (actual)

381

Serious AEs

12.1%

Results posted

Aug 2020

Primary outcome: Primary: Number of Participants Who Developed Foot Ulcer During Study Time Frame — 76; 82 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard therapy (Behavioral); PFC Stockings (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Developed Foot Ulcer During Study Time Frame	76; 82	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01221194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.