Wounds Clinical Trial
— TAPSOfficial title:
The AutoloGel™ Post-Market Surveillance (TAPS) Program
Verified date | February 2014 |
Source | Cytomedix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 131 |
Est. completion date | June 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Aiyan Diabetes Center | Augusta | Georgia |
United States | Providence Wound Institute | El Paso | Texas |
Lead Sponsor | Collaborator |
---|---|
Cytomedix | CTI Clinical Trial and Consulting Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | 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 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02865902 -
Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness
|
N/A | |
Terminated |
NCT01191567 -
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
|
N/A | |
Completed |
NCT01227759 -
Tyrosur® Gel-Investigation on Wound Healing Efficacy
|
Phase 2 | |
Recruiting |
NCT00737425 -
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
|
Phase 4 | |
Completed |
NCT00746109 -
Study of Wound Packing After Superficial Skin Abscess Drainage
|
Phase 4 | |
Withdrawn |
NCT00234559 -
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
|
N/A | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Recruiting |
NCT05588583 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
|
N/A | |
Completed |
NCT02591537 -
OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University
|
N/A | |
Completed |
NCT00792688 -
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
|
Phase 2 | |
Recruiting |
NCT05608317 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
|
N/A | |
Recruiting |
NCT02195063 -
Survey Study for Pain Management, Wound Care, Scar Care or UDT
|
Phase 4 | |
Completed |
NCT01319149 -
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
|
N/A | |
Completed |
NCT00153452 -
Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners
|
N/A | |
Completed |
NCT06083740 -
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
|
||
Not yet recruiting |
NCT02672280 -
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02314416 -
Stem Cells In Wound Healing With Collagen Matrix as a Carrier
|
Phase 4 | |
Recruiting |
NCT01454167 -
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications
|
N/A | |
Completed |
NCT01921725 -
The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
|
N/A |