Status:
COMPLETED
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Lead Sponsor:
Pfizer
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 hea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00662831
Start Date
April 1 2008
End Date
October 1 2010
Last Update
December 19 2018
Active Locations (63)
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1
Pfizer Investigational Site
Klagenfurt, Austria, A-9020
2
Pfizer Investigational Site
Vienna, Austria, A-1030
3
Pfizer Investigational Site
Vienna, Austria, A-1090
4
Pfizer Investigational Site
Ransart, Belgium, 6043