Cellular and Tissue Based Therapy Registry

Pressure Ulcer Clinical Trial

— CTPR  

Official title:

The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02322554
• Other study ID #: CDR002
• Status: Recruiting
• Start date: January 2005

Study information

• Verified date: April 2018
• Source: U.S. Wound Registry
• Contact: Caroline E Fife, MD
• Phone: 800-603-7896
• Email: cfife[@]uswoundregistry.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide comparative effectiveness data for patients with chronic wounds and ulcers and to understand whether clinical practice guidelines are followed in the use of these products. These products are referred to by a variety of names of which are inaccurate reflections of their structure or purpose (e.g. Cellular and Engineered Tissue Alternatives, "bioengineered tissues," "biological dressings"). The preferred term is cellular and/or tissue based products (CTPs). CTPs are utilized for their biological influence on the healing process by stimulating or supporting healing. They may or may not be incorporated into regenerating tissue. Both tissue derived and biosynthetic products may be made with or without dead cells and biomaterials made of living cells may be comprised of autologous cells (cultured and not cultured), xenogenic, or allogenic cells (minimally manipulated, cultured, immortal).The diversity of products and the rate at which they are becoming available for clinical use make it impossible to perform randomized controlled trials to compare their effectiveness against one another. Effectiveness in real world patients is the best current option to understand the role of CTPs in wound healing.

Hospital based outpatient wound centers participating in the US Wound Registry agree to provide data as part of quality initiatives and to meet their Stage 2 Meaningful use criteria. The CTPR is a subset of the USWR data. All patient data from all participating outpatient clinics are transmitted to the USWR where it is available for benchmarking, PQRS and other initiatives. Data used for effectiveness research is HIPAA de-identified. These data are derived from structured language entries directly transmitted from electronic health records which also link to billing and charge documents once practitioners sign and lock charts, confirming the veracity of data entries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients receiving cellular and tissue based products

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Non Healing Wound
• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Pressure Ulcer
• Surgical Wound
• Surgical Wound Dehiscence
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer
• Wounds and Injuries

Intervention

Biological:
• Cellular and tissue based products
Procedure: Application of device or biological to wounds

Locations

Country	Name	City	State
United States	St. Luke's Wound Care Clinic	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Wound Registry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	Healing or wound closure by wound type and stratified by Wound Healing Index	12 months