Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
NCT00662831
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- 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
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Diabetic Foot Ulcer | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 276 | |||
Original Estimated Enrollment ICMJE | 645 | |||
Actual Study Completion Date ICMJE | October 2010 | |||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Italy, Lithuania, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom | |||
Removed Location Countries | Czech Republic, France, Netherlands | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00662831 | |||
Other Study ID Numbers ICMJE | A6301083 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |