Recruiting

Cellular Therapy

Sponsor:

U.S. Wound Registry

Code:

NCT02322554

Conditions

Diabetic Foot Ulcers

Venous Stasis Ulcer

Pressure Ulcer

Chronic Non Healing Wound

Surgical Wound Dehiscence

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cellular and tissue based products

Study Details

Brief summary:

The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.

Conditions

Diabetic Foot Ulcers

Venous Stasis Ulcer

Pressure Ulcer

Chronic Non Healing Wound

Surgical Wound Dehiscence

Study ID

NCT02322554

Start date

Jan, 2005

Status verified date

Apr, 2018

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients receiving cellular and tissue based products

Exclusion Criteria:

  • none

Study Design

Enrollment

50000 participants

Anticipated

Interventions and Outcome Measures

Arms

wounds treated with CTPs

All cellular and tissue based products currently reimbursed in the hospital based outpatient department, administered at intervals as determined in the course of clinical practice

Interventions

Cellular and tissue based products

Procedure: Application of device or biological to wounds

Primary outcome measure

  • Healing [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Caroline E Fife, MD

800-603-7896cfife@uswoundregistry.com

Monica Weir

800-603-7896monica.weir@intellicure.com

Locations

St. Luke's Wound Care Clinic

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Caroline Fife, MD

936-266-2150Cfife@intellicure.com

Sherrill White Wolfe

(936) 266-2150swhitewolfe@stlukeshealth.org

More Information

Sponsor

U.S. Wound Registry

Last update posted

May 1, 2018

Last verified

Apr, 2018

Keywords

  • electronic health records
  • Qualified Clinical Data Registry
  • PQRS
  • quality reporting
  • cellular based products
  • bioengieered skin
  • USWR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by U.S. Wound Registry on 2018-05-01.