The AutoloGel™ Post-Market Surveillance (TAPS) Program
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 ]
| 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) |
-
Device: AutoloGel System
- platelet-rich plasma (PRP) gel
- such as leg ulcers, pressure ulcers, diabetic ulcers
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 |
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| Contact: Suzette L Arch, BA, BS | 240-499-2680 | sarch@cytomedix.com |
| Contact: Carelyn Fyling, RN | 218-547-4142 | cfyling@EOT.COM |
| United States, District of Columbia | |
| Specialty Hospital of Washington - Hadley | Withdrawn |
| Washington, District of Columbia, United States, 20032 | |
| United States, Georgia | |
| Aiyan Diabetes Center | Recruiting |
| Augusta, Georgia, United States, 30809 | |
| Contact: Elangovan Gopal, PhD 706-868-0319 adhielango@yahoo.com | |
| Contact: Jayabalan Sivakumar, PhD 706-868-0319 chola_jk@yahoo.com | |
| Principal Investigator: Janaki Nadarajah, DPM | |
| United States, Nevada | |
| VA Southern Nevda | Withdrawn |
| Las Vegas, Nevada, United States, 89191 | |
| United States, Texas | |
| Providence Wound Institute | Recruiting |
| El Paso, Texas, United States, 79902 | |
| Contact: Thelma Diaz, RN 915-577-7840 Thelma.Diaz@Tenethealth.com | |
| Contact: Teresa Isaacs 915-577-6891 Teresa.Isaacs@Tenethealth.com | |
| Principal Investigator: Gregory H Szeyko, MD, MS, CWS | |
| 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: | Martin Rosendale, CEO, Cytomedix |
| ClinicalTrials.gov Identifier: | NCT00762138 History of Changes |
| Other Study ID Numbers: | CM 306 |
| Study First Received: | September 24, 2008 |
| Last Updated: | August 20, 2010 |
| 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:
|
Leg Ulcer Pressure 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 May 19, 2013