The AutoloGel™ Post-Market Surveillance (TAPS) Program

NCT00762138 | Terminated DMC

• 1 other identifier: CM 306
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Platelet rich plasma; wounds; leg ulcers; pressure ulcers; diabetic ulcers; management of mechanically or surgically-debrided wounds

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (1)

• 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

  3 years

Study Arms (1)

Autologel System

OTHER

Autologel System produces platelet rich plasma gel

Device: AutoloGel System

Interventions

AutoloGel System DEVICE

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

Also known as: platelet-rich plasma (PRP) gel, such as leg ulcers, pressure ulcers, diabetic ulcers

Autologel System

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytomedix: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (2)

Aiyan Diabetes Center

Augusta, Georgia, 30809, United States

Location

Providence Wound Institute

El Paso, Texas, 79902, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Wounds and Injuries; Leg Ulcer; Pressure Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

US (2)