NCT00044746

Brief Summary

Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Oct 2000

Typical duration for phase_4 diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

September 4, 2002

Last Update Submit

February 7, 2013

Conditions

Diabetes MellitusDiabetic Foot

Keywords

Diabetes

Interventions

Piperacillin/TazobactamDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diabetes mellitus
  • Inpatient
  • Have 1 or more infected ulcer(s) below the ankle

You may not qualify if:

  • Must not have gangrene or severely impaired arterial supply in your foot
  • Must not have a bone infection in the area of your ulcer
  • Must not have allergies to penicillins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusDiabetic Foot

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2002

First Posted

September 6, 2002

Study Start

October 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

February 8, 2013

Record last verified: 2013-02