NCT01221194

Brief Summary

  1. 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. 2.To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable diabetes

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

5.3 years

First QC Date

October 13, 2010

Results QC Date

August 12, 2020

Last Update Submit

August 12, 2020

Conditions

Diabetes

Keywords

diabetesfoot ulcer preventiontherapeutic stockings

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Developed Foot Ulcer During Study Time Frame

    An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.

    30 months

Study Arms (2)

Standard therapy

ACTIVE COMPARATOR

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

Behavioral: Standard therapy

PFC Stockings

ACTIVE COMPARATOR

The stocking therapy group will be given PFC shear reducing stockings to wear.

Device: PFC Stockings

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.

Standard therapy
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.

PFC Stockings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Parkland Health & Hospital Systems

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Scott & White

Temple, Texas, 76502, United States

Location

University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Lawrence Lavery, DPM, MPH
Organization
UT Southwestern Medical Center at Dallas
Larry.Lavery@UTSouthwestern.edu
214-645-0544

Study Officials

  • Lawrence Lavery, DPM

    UT Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

August 26, 2020

Results First Posted

August 26, 2020

Record last verified: 2020-08

Locations

GB(1)US(3)