DiabetesPhase 2NCT02158442
Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
A Phase 2 study testing Percutaneous Isolated Limb Perfusion (PILP) delivery and Timentin in people with Diabetes and Infection, run by Osprey Medical, Inc at 1 site in Australia.
Trial summary
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Percutaneous Isolated Limb Perfusion (PILP) delivery and Timentin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2013to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.
Read the detailed description
During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.
- Being tested
- Percutaneous Isolated Limb Perfusion (PILP) delivery, Timentin
- Keywords
- Diabetes, Lower limb infection, Significant wound infections, Intravenous antibiotics, Timentin
- Medical subject headings
- Diabetes Mellitus, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Isolated Limb Perfusion (PILP) deliveryProcedure or surgery
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.
TimentinDrug
Also called Ticarcillin and Clavulanate
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The Treatment Group received intravenous Timentin prior to their PILP procedure. Receives: Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery; Drug: Timentin |
| Control Group | Active comparator | The Control Group received standard dosings of intravenous Timentin plus other standard care. Receives: Drug: Timentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the 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.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osprey Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Wraight, Assoc. Prof., Principal investigator, Royal Melbourne Hospital, Head, Diabetic Foot Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158442
- Sponsor's protocol ID
- O-PILP-C01 - Part B
- Status last verified
- Aug 2016
- First submitted
- 11 Apr 2014
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02158442
- Acronym / sponsor ID
- O-PILP-C01 - Part B
- Keywords
- Diabetes, Lower limb infection, Significant wound infections, Intravenous antibiotics, Timentin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Osprey Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.
Detailed description
During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery, Drug: TimentinThe Treatment Group received intravenous Timentin prior to their PILP procedure. |
| Control Group | Active comparator | Drug: TimentinThe Control Group received standard dosings of intravenous Timentin plus other standard care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Percutaneous Isolated Limb Perfusion (PILP) deliveryThe 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. | Procedure or surgery | Treatment Group |
| TimentinAlso: Ticarcillin and ClavulanateThe Control Group will receive standard dosings of intravenous Timentin plus other standard care. | Drug | Control Group, Treatment Group |
Primary outcome
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.
Time frame: Day 3
Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Paul Wraight, Assoc. Prof. principal investigator
Royal Melbourne Hospital, Head, Diabetic Foot Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Percutaneous Isolated Limb Perfusion (PILP) delivery and Timentin in people with Diabetes and Infection, run by Osprey Medical, Inc at 1 site in Australia.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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. (time frame: Day 3). 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 30 Sep 2016.