The AutoloGel™ Post-Market Surveillance (TAPS) Program

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The AutoloGel™ Post-Market Surveillance (TAPS) Program
This study is not yet open for participant recruitment.
Verified by Cytomedix, September 2008
Sponsors and Collaborators: Cytomedix
CTI Clinical Trial and Consulting Services

Information provided by: Cytomedix
ClinicalTrials.gov Identifier: NCT00762138

Purpose
AutoloGel™ Post-Market Surveillance Program

Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.

Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300

Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds.

Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors.

Condition Intervention
Wounds
Leg Ulcers
Pressure Ulcers
Diabetic Foot Ulcers
Device: AutoloGel System

MedlinePlus related topics: Bleeding Disorders Diabetic Foot Foot Health Leg Injuries and Disorders Pressure Sores
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type:Interventional
Study Design:Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:The AutoloGel™ Post-Market Surveillance (TAPS) Program

Further study details as provided by Cytomedix:

Primary Outcome Measures:
Assess the incidence of hematological immunologic other ae's assoc with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechchanically or surgically debrided wounds [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Absence of coagulopathies caused by inhibitors to coagulation Factor V as determ. by a significant prolongation of the (PT) time and confirmed by sever depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:300
Study Start Date:September 2008
Estimated Study Completion Date:December 2011
Estimated Primary Completion Date:September 2011 (Final data collection date for primary outcome measure)

Intervention Details:
Device: AutoloGel System
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management , such as:

Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects with diabetic ulcers Bowel and bladder care for subjects with pressure ulcers at risk for contamination Management of underlying disease

Show Detailed Description

Eligibility
Ages Eligible for Study:18 Years to 95 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Yes
Criteria
Inclusion Criteria:

A patient who meets all the following criteria will be enrolled in the postmarket surveillance program:
Presents with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.
Male or female subject of any race, and 18 to 95 years old.
Exclusion Criteria:

Study investigator(s) shall follow the Contraindications, Precautions, and Warnings relevant to subjects enrolled for treatment of wounds;
Subjects will be excluded from the trial if any of the following criteria are met:
If the Subject is on Coumadin medication (or another medication that is known to affect a potential coagulopathy) and has an elevated PT (prothrombin time) at the alert level at baseline, he/she will NOT be enrolled in the surveillance program.
Ensure the patient does not have any Contraindications as noted in the AutoloGel System Instructions for use, specifically:
Patients known to be sensitive to components and / or materials of bovine origin
Patients on chemotherapeutic agents
Patients with the following abnormal laboratory test levels

hemoglobin <10.5 g/dL
platelet count <100 x 109/L
serum albumin level < 2.5 g/dL
Wounds due to malignancy
Wounds with active clinically diagnosed infection
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762138

Contacts
Contact: Suzette L Arch, BA, BS 240-499-2680 sarch@cytomedix.com
Contact: Carelyn Fyling, RN 218-547-4142 cfyling@EOT.COM

Sponsors and Collaborators
Cytomedix
CTI Clinical Trial and Consulting Services
More Information

Related Info

Responsible Party:Cytomedix ( Martin Rosendale, CEO )
Study ID Numbers:CM 306
First Received:September 24, 2008
Last Updated:September 29, 2008
ClinicalTrials.gov Identifier:NCT00762138 [history]
Health Authority:United States: Institutional Review Board

Keywords provided by Cytomedix:
Platelet rich plasma
wounds
leg ulcers
pressure ulcers
diabetic ulcers
management of mechanically or surgically-debrided wounds

Study placed in the following topic categories:
Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Pressure Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases