Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (FEENICS)
Tracking Information
Start Date ICMJE | April 2008 |
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Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 17, 2008) | Number of subjects with ≥50% reduction in ulcer surface area including intact skin healing. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00662831 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 17, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients |
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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 | |
Study Phase | Phase II, Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Condition ICMJE | Diabetic Foot Ulcer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 645 | ||||
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Estimated Completion Date | November 2010 | ||||
Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Greece, Italy, Lithuania, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00662831 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A6301083 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/