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Therapeutic Stockings to Prevent Foot Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01221194
First received: October 13, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose
  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.

Condition Intervention
Diabetes
Behavioral: Standard therapy
Device: PFC Stockings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Therapeutic Stockings to Prevent Foot Ulcers

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • The main clinical outcome is ulceration of the foot to evaluate the effectiveness of a stocking as a prevention tool [ Time Frame: every 12 weeks for 30 months ] [ Designated as safety issue: No ]
    An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures. Secondary clinical outcomes will include infection, Charcot Arthropathy, and amputation. An infection will be defined as a patient with three of six clinical signs of infection (erythema, heat, edema, pain, loss of function, purulence) or leukocytosis. Osteomyelitis will be diagnosed when radiographic and clinical signs are consistent with bone infection. This will be confirmed with bone biopsy, culture and histopathology when appropriate.


Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard therapy
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
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
Active Comparator: PFC Stockings
The stocking therapy group will be given PFC shear reducing stockings to wear.
Device: PFC Stockings
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221194

Contacts
Contact: Lawrence Lavery, DPM 214-645-0544 LLAVE1@mednet.swmed.edu
Contact: Cecilia Lara 214-645-2377 Cecilia.Lara@utsouthwestern.edu

Locations
United States, Texas
Parkland Health & Hospital Systems Recruiting
Dallas, Texas, United States, 75235
Contact: Lawrence Lavery, DPM    214-645-0544    LLAVE1@mednet.swmed.edu   
Contact: Cecilia Lara    214-645-2377    Cecilia.Lara@utsouthwestern.edu   
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Lawrence Lavery, DPM    214-645-0544    LLAVE1@mednet.swmed.edu   
Contact: Cecilia Lara    214-645-2377    Cecilia.Lara@utsouthwestern.edu   
Scott & White Recruiting
Temple, Texas, United States
Contact: Douglas Murdoch, DPM    214-771-7604    DMurdoch@swmail.sw.org   
United Kingdom
University of Manchester Recruiting
Manchester, United Kingdom
Contact: Andrew Boulton, MD    +44-161-276-4452    andrew.j.boulton@manchester.ac.uk   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Lawrence Lavery, DPM UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: Lawrence Lavery, DPM, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT01221194     History of Changes
Other Study ID Numbers: UTSW - 7R01DK070046-04
Study First Received: October 13, 2010
Last Updated: October 13, 2010
Health Authority: United States: National Institute of Diabetes and Digestive and Kidney Diseases

Keywords provided by University of Texas Southwestern Medical Center:
diabetes
foot ulcer prevention
therapeutic stockings

Additional relevant MeSH terms:
Foot Ulcer
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 24, 2014