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


Tracking Information

Start Date  ICMJEApril 2008
Estimated Primary Completion DateNovember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2008)		Number of subjects with ≥50% reduction in ulcer surface area including intact skin healing. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00662831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 17, 2008)
  • Number of subjects who have intact skin healing. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of patients who underwent amputation (major and minor). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Official Title  ICMJEA 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients
Brief 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.

Detailed Description 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Condition  ICMJEDiabetic Foot Ulcer
Intervention  ICMJE
  • 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.
Study Arms / Comparison Groups
  • Active: Experimental
    Active study treatment
    Intervention: Drug: Fragmin/ Dalteparin Sodium
  • Placebo: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo for Fragmin/ Dalteparin Sodium

Recruitment Information

Estimated Enrollment  ICMJE645
Estimated Completion DateNovember 2010
Estimated Primary Completion DateNovember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects 18 years of age with type 1 or type 2 diabetes.
  • Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of >3

Exclusion Criteria:

  • Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
  • Subjects with a known bleeding disorder or evidence of active bleeding.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEAustria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Italy,   Lithuania,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00662831
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA6301083
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer