The AutoloGel™ Post-Market Surveillance (TAPS) Program

Summary

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.

Conditions

• Wounds
• Leg Ulcers
• Pressure Ulcers
• Diabetic Foot Ulcers

Interventions

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

Sponsors & Collaborators

• CTI Clinical Trial and Consulting Services

  collaborator OTHER

• Cytomedix

  lead INDUSTRY

Principal Investigators

• Macy G Hall, MD · Speciality Hospital of Washington - Hadley

• John G Martinez, MD · VA Southern Nevda

• Janaki Nadarajah, DPM · Aiyan Diabetes Center

• Gregory H Szeyko, MD · Providence Wound Institute

Study Design

Allocation

NA

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2012-05-31

Completion

2012-06-30

Countries

• United States

Study Locations