Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

NCT00662831 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2018-12-19

Study results available
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Summary

The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Fragmin/ Dalteparin Sodium

Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.

DRUG

Placebo for Fragmin/ Dalteparin Sodium

Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Italy
  • Lithuania
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662831 on ClinicalTrials.gov