The Diabetic Foot Ulcer Registry

NCT02813161 | Unknown DMC

• 1 other identifier: CDR005
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer Outcome; Quality of Patient Care

Keywords

diabetic foot ulcer; diabetes; arterial disease; neuropathy; amputation; QCDR; quality measure; wound

Outcome Measures

Primary Outcomes (4)

• Wound healing

  wound closure

  6 months

• major amputation

  above the knee, below the knee

  6 months

• minor amputation with preservation of ambulation

  toe amputation, transmetatarsal

  6 months

• Death

  death without wound closure

  6 months

Secondary Outcomes (2)

• Patient Quality of life

  12 weeks

• Patient Reported Outcome

  12 months

Interventions

cellular and tissue based therapy BIOLOGICAL

Also known as: Apligraf, Dermagraft, Theraskin, Epifix, Dermapure, Graffix, Talymed

negative pressure wound therapy DEVICE

Also known as: The VAC, Pico, SnAP

debridement PROCEDURE

advanced wound therapy PROCEDURE

Nutritional screening DIETARY_SUPPLEMENT

off-loading DEVICE

Also known as: TCC EZ-Cast, Total Contact Casting, CROW walker, shoe modification

Hyperbaric oxygen Therapy DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry

You may qualify if:

• All patients with diabetic foot ulcers seen by the practitioner

You may not qualify if:

• None

Sponsors & Collaborators

• U.S. Wound Registry: lead
• APMA: collaborator

Study Sites (1)

CHI St. Luke's The Woodlands

The Woodlands, Texas, 77384, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries

Interventions

Cell Count; Apligraf; TransCyte; Negative-Pressure Wound Therapy; Debridement; Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena; Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Oxygen Inhalation Therapy; Respiratory Therapy

Central Study Contacts

Monica Weir, MBA, CCRP

CONTACT

(800) 603-7896; monica.weir@uswoundregistry.com

Caroline E Fife, MD

CONTACT

(800) 603-7896; cfife@uswoundregistry.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 24, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

US (1)