E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 arteria? occlusive disease (PAOD) and peripheral neuropathy. |
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E.2.2 | Secondary objectives of the trial |
Evaluating the number of diabetic patients with chronic neuroischaemic foot ulcers who have improved ulcers at baseline that develop intact skin healing.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects ? 18 years of age. 2. Subjects must have completed the 6 month study duration in the A6301083 study. 3. 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. 4. All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system. 5. Subjects must be on a minimum of 75 mg of aspirin (or equivalent dose of calcium carbasalate) daily for at least 4 weeks prior to randomization and the aspirin/ calcium carbasalate therapy must be continued for the entire duration of the study. 6. Subjects must be willing to comply with the protocol, scheduled visits, laboratory tests and medication regimen. 7. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. |
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E.4 | Principal exclusion criteria |
1. Subjects who have the following: ユ 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). ユ 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. 2. Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system. 3. Subjects with a known bleeding disorder or evidence of active bleeding. 4. Subjects who are on dialysis. ユ Subjects who where found to be major protocol violators in A6301083 study. ユ Subjects who did not complete the 6 month study period of the A6301083 study. 5. Subjects who have undergone a major organ transplant and/or treatment with immunosuppressive agents. 6. Subjects who have participated in a study of an investigational drug or device within four weeks of study entry (excluding the A6301083 study). 7. Subjects with malignant ulcers, all subjects with clinically suspicious ulcers will require a biopsy to exclude a malignancy prior to enrolment. 8. Female subjects who are pregnant, lactating, or planning a pregnancy during the course of the study, or who are of child bearing potential and not using an aceptable method of birth control. Female subjects should continue contraceptive methods during the study and for at least 30 days after receiving their last treatment. 9. Subjects treated with anticoagulants or anti-platelet therapy (other than aspirin/ or calcium carbasalate) such as warfarin, clopidogrel, or low molecular weight heparins. 10. Abuse of alcohol and/or any other drug in the opinion of the investigator. 11. Subjects with contraindications to dalteparin administration, which include: ユ Known hypersensitivity to the active ingredient in dalteparin or to any of the excipients of this product. ユ History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia. ユ Severe hypertension. ユ Acute gastroduodenal ulcer, cerebral hemorrhage or known hemorrhagic diathesis. ユ Subacute endocarditis. ユ Injuries to and operations on the central nervous system, eyes and ears (within the last month). 12. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
ユ The number of all hemorrhages (this includes minor and major). ユ The number of major hemorrhages. ユ The number of minor hemorrhages. ユ The number of clinically relevant minor hemorrhages. ユ The number of minor trivial hemorrhages. ユ Incidence, severity, and relatedness to treatment of all reported and treatment emergent adverse events and withdrawals from the trial due to adverse events. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |