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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02158442




Registration number
NCT02158442
Ethics application status
Date submitted
11/04/2014
Date registered
6/06/2014

Titles & IDs
Public title
Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
Scientific title
Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection
Secondary ID [1] 0 0
O-PILP-C01 - Part B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Percutaneous Isolated Limb Perfusion (PILP) delivery
Treatment: Drugs - Timentin

Experimental: Treatment Group - The Treatment Group received intravenous Timentin prior to their PILP procedure.

Active comparator: Control Group - The Control Group received standard dosings of intravenous Timentin plus other standard care.


Treatment: Surgery: 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.

Treatment: Drugs: Timentin
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.
Timepoint [1] 0 0
Day 3

Eligibility
Key inclusion criteria
* M or F subjects 18 - 90 years old
* 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
* PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Allergy to contrast media
* 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
* PROCEDURAL EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device
* Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Osprey Medical, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Wraight, Assoc. Prof.
Address 0 0
Royal Melbourne Hospital, Head, Diabetic Foot Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02158442