|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00662831 |
Purpose
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.
|
Eligibility| 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.
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 77 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6301083 |
| Study First Received: | April 16, 2008 |
| Last Updated: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00662831 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Diabetic Foot Ulcers, Neuroischaemic |
|
Foot Ulcer Anticoagulants Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Fibrinolytic Agents Cardiovascular Agents |
Foot Diseases Diabetic Angiopathies Fibrin Modulating Agents Dalteparin Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
|
Foot Ulcer Anticoagulants Molecular Mechanisms of Pharmacological Action Diabetic Neuropathies Skin Diseases Ulcer Hematologic Agents Vascular Diseases Diabetes Mellitus Endocrine System Diseases Fibrinolytic Agents Cardiovascular Agents |
Foot Diseases Pharmacologic Actions Diabetic Angiopathies Fibrin Modulating Agents Pathologic Processes Dalteparin Therapeutic Uses Cardiovascular Diseases Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
