Penetration of Ertapenem Into Bone

Amputation Clinical Trial

Official title: Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation

Status Withdrawn

Clinical Trial Summary

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues

Clinical Trial Description

Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.

Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.

Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:

• -2 days prior the amputation

• -1 day prior the amputation

• 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.

Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Peripheral Vascular Diseases

• NCT number: NCT00392028
• Study type: Interventional
• Source: HaEmek Medical Center, Israel
• Status: Withdrawn
• Phase: N/A
• Start date: November 2006
• Completion date: July 2007