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

NCT ID: NCT00662831

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Diabetic Foot Ulcer

Keywords

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Diabetic Foot Ulcers Neuroischaemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Active study treatment

Group Type EXPERIMENTAL

Fragmin/ Dalteparin Sodium

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo for Fragmin/ Dalteparin Sodium

Intervention Type DRUG

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

Interventions

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Fragmin/ Dalteparin Sodium

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

Intervention Type DRUG

Placebo for Fragmin/ Dalteparin Sodium

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Klagenfurt, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Ransart, , Belgium

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Winnipeg, Manitoba, Canada

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Montreal, Quebec, Canada

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Prague, , Czechia

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Prague, , Czechia

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Zlín, , Czechia

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Aalborg, , Denmark

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Aarhus C, , Denmark

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Hvidovre, , Denmark

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Koebenhavn NV, , Denmark

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Odense C, , Denmark

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Sønderborg, , Denmark

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Tampere, , Finland

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Karlsbad, , Germany

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Athens, , Greece

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Athens, , Greece

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Melissia/Athens, , Greece

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Thessaloniki, , Greece

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San Giovanni Rotondo, FG, Italy

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Florence, , Italy

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Pisa, , Italy

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Roma, , Italy

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Tønsberg, , Norway

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Gdansk, , Poland

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Lodz, , Poland

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Puławy, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Getafe, Madrid, Spain

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Girona, , Spain

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Madrid, , Spain

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Karlstad, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Barnsley, , United Kingdom

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Birmingham, , United Kingdom

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Colchester, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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Ipswich, , United Kingdom

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Manchester, , United Kingdom

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Manchester, , United Kingdom

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Peterborough, , United Kingdom

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Countries

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

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301083&StudyName=Study%20Of%20The%20Effect%20Of%20Fragmin%20In%20The%20Treatment%20Of%20Neuroischaemic%20Foot%20Ulcers%20In%20Diabetic%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6301083

Identifier Type: -

Identifier Source: org_study_id