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The Diabetic Foot Ulcer Registry (DFUR)

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ClinicalTrials.gov Identifier: NCT02813161
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
American Podiatric Medical Association
Information provided by (Responsible Party):
U.S. Wound Registry

Brief Summary:
This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

Condition or disease Intervention/treatment
Diabetic Foot Ulcer Outcome Quality of Patient Care Biological: cellular and tissue based therapy Device: negative pressure wound therapy Procedure: debridement Procedure: advanced wound therapy Dietary Supplement: Nutritional screening Device: off-loading Device: Hyperbaric oxygen Therapy

Detailed Description:
This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
Study Start Date : February 2015
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Biological: cellular and tissue based therapy
    Other Names:
    • Apligraf
    • Dermagraft
    • Theraskin
    • Epifix
    • Dermapure
    • Graffix
    • Talymed
    Device: negative pressure wound therapy
    Other Names:
    • The VAC
    • Pico
    • SnAP
    Procedure: debridement Procedure: advanced wound therapy Dietary Supplement: Nutritional screening Device: off-loading
    Other Names:
    • TCC EZ-Cast
    • Total Contact Casting
    • CROW walker
    • shoe modification
    Device: Hyperbaric oxygen Therapy


Primary Outcome Measures :
  1. Wound healing [ Time Frame: 6 months ]
    wound closure

  2. major amputation [ Time Frame: 6 months ]
    above the knee, below the knee

  3. minor amputation with preservation of ambulation [ Time Frame: 6 months ]
    toe amputation, transmetatarsal

  4. Death [ Time Frame: 6 months ]
    death without wound closure


Secondary Outcome Measures :
  1. Patient Quality of life [ Time Frame: 12 weeks ]
    W-QoL score

  2. Patient Reported Outcome [ Time Frame: 12 months ]
    using patient reported outcome quality measure



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry
Criteria

Inclusion Criteria:

  • All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813161


Contacts
Contact: Monica Weir, MBA, CCRP (800) 603-7896 monica.weir@uswoundregistry.com
Contact: Caroline E Fife, MD (800) 603-7896 cfife@uswoundregistry.com

Locations
United States, Texas
CHI St. Luke's The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Contact: Sherrill White Wolfe    936-266-2150    swhitewolfe@StLukesHealth.org   
Sponsors and Collaborators
U.S. Wound Registry
American Podiatric Medical Association

Responsible Party: U.S. Wound Registry
ClinicalTrials.gov Identifier: NCT02813161     History of Changes
Other Study ID Numbers: CDR005
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by U.S. Wound Registry:
diabetic foot ulcer
diabetes
arterial disease
neuropathy
amputation
QCDR
quality measure
wound

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases