The AutoloGel™ Post-Market Surveillance (TAPS) Program

This study has been terminated.
(Discontinued due to favorable results)
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Cytomedix
ClinicalTrials.gov Identifier:
NCT00762138
First received: September 24, 2008
Last updated: February 25, 2014
Last verified: February 2014
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The AutoloGel™ Post-Market Surveillance (TAPS) Program

Resource links provided by NLM:


Further study details as provided by Cytomedix:

Primary Outcome Measures:
  • Assess the incidence of hematological immunologic other ae's association with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechanically 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 determined by a significant prolongation of the (PT) time. Depletion of Factor V activity with a positive Bethesda Assay [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autologel System
Autologel System produces platelet rich plasma gel
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

Other Names:
  • platelet-rich plasma (PRP) gel
  • such as leg ulcers, pressure ulcers, diabetic ulcers

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Aiyan Diabetes Center
Augusta, Georgia, United States, 30809
United States, Texas
Providence Wound Institute
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Cytomedix
CTI Clinical Trial and Consulting Services
Investigators
Principal Investigator: Macy G Hall, MD Speciality Hospital of Washington - Hadley
Principal Investigator: John G Martinez, MD VA Southern Nevda
Principal Investigator: Janaki Nadarajah, DPM Aiyan Diabetes Center
Principal Investigator: Gregory H Szeyko, MD Providence Wound Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT00762138     History of Changes
Other Study ID Numbers: CM 306
Study First Received: September 24, 2008
Last Updated: February 25, 2014
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

Additional relevant MeSH terms:
Pressure Ulcer
Leg Ulcer
Ulcer
Foot Ulcer
Diabetic Foot
Skin Ulcer
Skin Diseases
Pathologic Processes
Foot Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 15, 2014