The AutoloGel™ Post-Market Surveillance (TAPS) Program

NATerminatedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

May 31, 2012

Study Completion Date

June 30, 2012

Conditions
WoundsLeg UlcersPressure UlcersDiabetic 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"

Trial Locations (2)

30809

Aiyan Diabetes Center, Augusta

79902

Providence Wound Institute, El Paso

Sponsors
All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

lead

Cytomedix

INDUSTRY