Clinical trial NCT00662831: Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Official title: A 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcers Neuroischaemic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
timeFrame: Week 24 [end of treatment (EOT)] or early termination
Secondary outcomes:
measure: Number of Participants With Intact Skin Healing
timeFrame: Week 24 (EOT) or early termination
measure: Number of Participants Who Underwent Any Amputation
timeFrame: Week 24 (EOT) or early termination
measure: Number of Participants Who Underwent Major and Minor Amputation
timeFrame: Week 24 (EOT) or early termination
measure: Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing
timeFrame: Week 24 (EOT) or early termination
measure: Number of Participants Who Died
timeFrame: Week 24 (EOT) or early termination
measure: Number of Participants With Major Cardiovascular Disease Events (MCVE)
timeFrame: Week 24 (EOT) or early termination
measure: Time to Intact Skin Healing
timeFrame: Week 24 (EOT) or early termination
measure: Median Time to First Amputation
timeFrame: Week 24 (EOT) or early termination
measure: Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score
timeFrame: Baseline and Week 24 (EOT or early termination)
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
timeFrame: Baseline and Week 24 (EOT or early termination)
measure: 36-Item Short-Form Health Survey (SF-36) Score
timeFrame: Baseline and Week 24 (EOT or early termination)
measure: 11-point Likert Pain Scale
timeFrame: Baseline and Week 24 (EOT or early termination)
measure: Transcutaneous Local Tissue Oxygenation (pO2)
timeFrame: Baseline and Week 24 (EOT or early termination)
Other outcomes:
measure: Number of All Hemorrhages
timeFrame: Week 24 (EOT) or early termination
measure: Number of Major and Minor Hemorrhages
timeFrame: Week 24 (EOT) or early termination
measure: Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages
timeFrame: Week 24 (EOT) or early termination
Locations:
city: Klagenfurt
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Ransart
country: Belgium
facility: Pfizer Investigational Site
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Zlin
country: Czechia
facility: Pfizer Investigational Site
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Hvidovre
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn NV
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Soenderborg
country: Denmark
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Karlsbad
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Melissia/Athens
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: San Giovanni Rotondo
country: Italy
facility: Pfizer Investigational Site
state: FG
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Pulawy
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Getafe
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Malmö
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Barnsley
country: United Kingdom
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Colchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Ipswich
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: