WoundsTAPSNCT00762138
The AutoloGel™ Post-Market Surveillance (TAPS) Program
A study testing AutoloGel System in people with Wounds and Leg Ulcers, run by Cytomedix at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds, Leg Ulcers, Pressure Ulcers
- What is being tested?
- AutoloGel System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aiyan Diabetes Center
Augusta, Georgia, 30809
Providence Wound Institute
El Paso, Texas, 79902
About this study
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.
Read more
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.
Read the detailed description
Device Name.
The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the application BK060007.
The AutoloGel™ System includes.
AutoloGel™ Centrifuge II AutoloGel™ System Wound Dressing and Reagent Kits including single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel.
The Instructions for Use include a detailed description and procedures for making AutoloGel and a list of the Kit components which is provided at the end of the Instructions.
Indications for Use.
The AutoloGel™ System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own blood. Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Dosing.
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.
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
Precautions and Warnings.
Caution. Federal Law (U.S.A.) restricts this device to sale by or on the order of a Physician.
Precautions.
Throughout the processing procedure and application of AutoloGel™, use universal precautions as defined by the facility policy and procedure manual.
All parts of the procedure shall be performed in such a manner to minimize splashing, spraying, spattering, and generation of potential droplets.
Warnings.
AutoloGelTM is produced with the use of bovine thrombin. The use of topical bovine thrombin preparations has occasionally been associated with abnormalities of hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which have rarely been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and / or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and / or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Because of thrombin's action in the clotting mechanism, AutoloGel must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
- Conditions
- Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers
- Being tested
- AutoloGel System
- Keywords
- Platelet rich plasma, wounds, leg ulcers, pressure ulcers, diabetic ulcers, management of mechanically or surgically-debrided wounds
- Medical subject headings
- Wounds and Injuries, Leg Ulcer, Pressure Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoloGel SystemDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Autologel System | Other | Autologel System produces platelet rich plasma gel Receives: Device: AutoloGel System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: Discontinued due to favorable results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytomedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- Macy G Hall, MD, Principal investigator, Speciality Hospital of Washington - HadleyJohn G Martinez, MD, Principal investigator, VA Southern NevdaJanaki Nadarajah, DPM, Principal investigator, Aiyan Diabetes CenterGregory H Szeyko, MD, Principal investigator, Providence Wound Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762138
- Sponsor's protocol ID
- CM 306
- Acronym
- TAPS
- Status last verified
- Feb 2014
- First submitted
- 24 Sep 2008
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AutoloGel™ Post-Market Surveillance (TAPS) Program
- ClinicalTrials.gov ID
- NCT00762138
- Acronym / sponsor ID
- TAPS / CM 306
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to favorable results
- Enrolment
- 131 participants (actual)
- Lead sponsor
- CytomedixIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Device Name.
The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the application BK060007.
The AutoloGel™ System includes.
AutoloGel™ Centrifuge II AutoloGel™ System Wound Dressing and Reagent Kits including single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel.
The Instructions for Use include a detailed description and procedures for making AutoloGel and a list of the Kit components which is provided at the end of the Instructions.
Indications for Use.
The AutoloGel™ System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own blood. Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Dosing.
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.
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
Precautions and Warnings.
Caution. Federal Law (U.S.A.) restricts this device to sale by or on the order of a Physician.
Precautions.
Throughout the processing procedure and application of AutoloGel™, use universal precautions as defined by the facility policy and procedure manual.
All parts of the procedure shall be performed in such a manner to minimize splashing, spraying, spattering, and generation of potential droplets.
Warnings.
AutoloGelTM is produced with the use of bovine thrombin. The use of topical bovine thrombin preparations has occasionally been associated with abnormalities of hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which have rarely been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and / or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and / or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Because of thrombin's action in the clotting mechanism, AutoloGel must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologel System | Other | Device: AutoloGel SystemAutologel System produces platelet rich plasma gel |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutoloGel SystemAlso: platelet-rich plasma (PRP) gel, such as leg ulcers, pressure ulcers, diabetic ulcersThe 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 | Device | Autologel System |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Discontinued due to favorable results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Macy G Hall, MD principal investigator
Speciality Hospital of Washington - Hadley
John G Martinez, MD principal investigator
VA Southern Nevda
Janaki Nadarajah, DPM principal investigator
Aiyan Diabetes Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoloGel System in people with Wounds and Leg Ulcers, run by Cytomedix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Discontinued due to favorable results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.