Cellular and Tissue Based Therapy Registry

NCT02322554 | Unknown DMC

• 1 other identifier: CDR002
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Healing

  Healing or wound closure by wound type and stratified by Wound Healing Index

  12 months

Study Arms (1)

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

Biological: Cellular and tissue based products

Interventions

Cellular and tissue based products BIOLOGICAL

Procedure: Application of device or biological to wounds

Also known as: Apligraf, Dermagraft, Epifix, Oasis, Talymed, Primatrix, Theraskin, Grafix, Dermaspan, Alloderm, Amnioband, GraftJacket, Integra, Matristem

wounds treated with CTPs

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

All patients seen at participating hospital based outpatient wound centers to whom CTPs are applied

You may qualify if:

• patients receiving cellular and tissue based products

You may not qualify if:

• none

Sponsors & Collaborators

• U.S. Wound Registry: lead

Study Sites (1)

St. Luke's Wound Care Clinic

The Woodlands, Texas, 77384, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer; Surgical Wound Dehiscence

Interventions

Cell Count; Apligraf; TransCyte; poly(divinyl-co-N-vinylpyrrolidinone); Alloderm; integra artificial skin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena

Central Study Contacts

Caroline E Fife, MD

CONTACT

800-603-7896; cfife@uswoundregistry.com

Monica Weir

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2005
• Primary Completion: January 1, 2020
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)