Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
NCT ID: NCT02158442
Last Updated: 2016-09-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2013-10-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
The Treatment Group received intravenous Timentin prior to their PILP procedure.
Percutaneous Isolated Limb Perfusion (PILP) delivery
The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.
Timentin
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Control Group
The Control Group received standard dosings of intravenous Timentin plus other standard care.
Timentin
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Interventions
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Percutaneous Isolated Limb Perfusion (PILP) delivery
The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.
Timentin
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has pre-existing diabetes diagnosis
* Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life
* Consequence of infected wound would require Std of Care share debridement
* Subject willing and able to provide written informed consent
* Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations
Exclusion Criteria
* Known bleeding disorder including thrombocytopenia
* Recent AMI or elevated Troponin levels within last 30 days
* Penicillin sensitivity; Timentin sensitivity
* Female subjects known to be or suspected to be pregnant or lactating
* Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure
* Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment
* The PI determines the subject is not an appropriate subject for the study
* Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters
18 Years
90 Years
ALL
No
Sponsors
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Osprey Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Wraight, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Royal Melbourne Hospital, Head, Diabetic Foot Unit
Locations
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Royal Melbourne Hospital
Parkville, Victoria, Australia
Countries
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Other Identifiers
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O-PILP-C01 - Part B
Identifier Type: -
Identifier Source: org_study_id