Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00662831 |
To 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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Foot Ulcer |
Drug: Fragmin/ Dalteparin Sodium Drug: Placebo for Fragmin/ Dalteparin Sodium |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 645 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active: Experimental
Active study treatment
|
Drug: Fragmin/ Dalteparin Sodium
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
|
Placebo: Placebo Comparator
Placebo
|
Drug: Placebo for Fragmin/ Dalteparin Sodium
Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6301083 |
Study First Received: | April 16, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00662831 |
Health Authority: | United Kingdom: Research Ethics Committee |
Diabetic Foot Ulcers, Neuroishaemic |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Dalteparin Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |