The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
NCT00765063
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086) | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Diabetic Foot Ulcer | |||
| Intervention ICMJE | Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium Other Name: Dalteparin sodium | |||
| Study Arms ICMJE | Experimental: Active
Active study treatment Intervention: Drug: Fragmin | |||
| 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 | 62 | |||
| Original Estimated Enrollment ICMJE | 215 | |||
| 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, Czech Republic, Denmark, Germany, Greece, Italy, Norway, Poland, Russian Federation, Sweden, Ukraine, United Kingdom | |||
| Removed Location Countries | Lithuania, Spain | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00765063 | |||
| Other Study ID Numbers ICMJE | A6301086 | |||
| Has Data Monitoring Committee | No | |||
| 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 | December 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||