Recruiting

Observational Study

Sponsor:

U.S. Wound Registry

Code:

NCT02813161

Conditions

Diabetic Foot Ulcer Outcome

Quality of Patient Care

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

cellular and tissue based therapy

negative pressure wound therapy

debridement

advanced wound therapy

Nutritional screening

Study Details

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

Study ID

NCT02813161

Start date

Feb, 2015

Status verified date

Apr, 2018

Completion date

Feb, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients with diabetic foot ulcers seen by the practitioner

Exclusion Criteria:

  • None

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

cellular and tissue based therapy

negative pressure wound therapy

debridement

advanced wound therapy

Nutritional screening

off-loading

Hyperbaric oxygen Therapy

Primary outcome measure

  • Wound healing [ Time Frame: 6 months ]
  • major amputation [ Time Frame: 6 months ]
  • minor amputation with preservation of ambulation [ Time Frame: 6 months ]
  • Death [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Monica Weir, MBA, CCRP

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

Caroline E Fife, MD

(800) 603-7896cfife@uswoundregistry.com

Locations

CHI St. Luke's The Woodlands

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Sherrill White Wolfe

936-266-2150swhitewolfe@StLukesHealth.org

More Information

Sponsor

U.S. Wound Registry

Last update posted

May 3, 2018

Last verified

Apr, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by U.S. Wound Registry on 2018-05-03.