Phase 2
N=15
Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
Diabetes · Infection
Bottom Line
View on ClinicalTrials.gov: NCT02158442 ↗Enrolled (actual)
15
Serious AEs
7.7%
Results posted
Aug 2016
Primary outcome: Primary: 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. — 5; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Percutaneous Isolated Limb Perfusion (PILP) delivery (Procedure); Timentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Osprey Medical, Inc
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
5; 3 | — |
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.
Eligibility Criteria
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
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
Data sourced from ClinicalTrials.gov (NCT02158442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.