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The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Foot Ulcer

Intervention: Fragmin (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

Clinical Details

Official title: A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of All Hemorrhages

Number of Major Hemorrhages

Number of Minor Hemorrhages

Number of Clinically Relevant Minor Hemorrhages

Number of Trivial Hemorrhages

Secondary outcome:

Number of Participants With Intact Skin Healing

Number of Participants With Improved Ulcer Healing

Number of Participants Who Underwent Amputation

Time to Intact Skin Healing

Time to First Amputation

Number of Participants With Major Cardiovascular Disease Events (MCVE)

11-point Likert Pain Scale

36-Item Short-Form Health Survey (SF-36) Score

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have completed the 6 month study duration in the A6301083 study.

- Subjects must have a positive ulcer treatment response, defined as a reduction in the

study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.

- All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University

of Texas wound classification system Exclusion Criteria:

- Subjects who have the following:

- Intact skin healing (defined as 100% reduction in ulcer surface area with full

epithelialisation at or prior to the EOT visit in the A6301083 study).

- A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline

ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.

- Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the

University of Texas wound classification system.

- Subjects with a known bleeding disorder or evidence of active bleeding.

- Subjects who are on dialysis.

- Subjects who where found to be major protocol violators in A6301083 study.

- Subjects who did not complete the 6 month study period of the A6301083 study

Locations and Contacts

Pfizer Investigational Site, Wien A-1090, Austria

Pfizer Investigational Site, Ransart 6043, Belgium

Pfizer Investigational Site, Praha 5 150 06, Czech Republic

Pfizer Investigational Site, Zlin 760 01, Czech Republic

Pfizer Investigational Site, Aarhus C 8000, Denmark

Pfizer Investigational Site, Karlsbad 76307, Germany

Pfizer Investigational Site, Melissia/Athens 15127, Greece

Pfizer Investigational Site, Firenze 50139, Italy

Pfizer Investigational Site, Tonsberg 3103, Norway

Pfizer Investigational Site, Lodz 90-153, Poland

Pfizer Investigational Site, Pulawy 24-100, Poland

Pfizer Investigational Site, Warszawa 02-097, Poland

Pfizer Investigational Site, Wroclaw 51-124, Poland

Pfizer Investigational Site, Moscow 123423, Russian Federation

Pfizer Investigational Site, Moscow 127486, Russian Federation

Pfizer Investigational Site, Saint-Petersburg 194156, Russian Federation

Pfizer Investigational Site, Karlstad 651 85, Sweden

Pfizer Investigational Site, Malmo 205 02, Sweden

Pfizer Investigational Site, Stockholm 118 83, Sweden

Pfizer Investigational Site, Stockholm 171 76, Sweden

Pfizer Investigational Site, Stockholm 182 88, Sweden

Pfizer Investigational Site, Kharkiv 61002, Ukraine

Pfizer Investigational Site, Kyiv 02091, Ukraine

Pfizer Investigational Site, Lviv 79010, Ukraine

Pfizer Investigational Site, Birmingham B9 5SS, United Kingdom

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada

Pfizer Investigational Site, Moscow, Russia 119034, Russian Federation

Additional Information

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

Starting date: October 2008
Last updated: December 1, 2011

Page last updated: August 20, 2015

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