N/A Completed N=381 Randomized Single-blind Prevention

Therapeutic Stockings to Prevent Foot Ulcers

Diabetes

Source: ClinicalTrials.gov NCT01221194 ↗

Enrolled (actual)

381

Serious AEs

12.1%

Results posted

Aug 2020

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

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.

Outcome Measures

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

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. Informational only — not medical advice.