Conditions: Diabetes Infection
Keywords: Diabetes Lower limb infection Significant wound infections Intravenous antibiotics Timentin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: The Treatment Group received intravenous Timentin prior to their PILP procedure. arm 2: The Control Group received standard dosings of intravenous Timentin plus other standard care.

Interventions: intervention 1: Percutaneous Isolated Limb Perfusion (PILP) delivery intervention 2: Timentin
Intervention descriptions: intervention 1: 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. intervention 2: The Control Group will receive standard dosings of intravenous Timentin plus other standard care.

Protocol document: