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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	24 July 2012
Main ID:	EUCTR2008-001566-90-DK
Date of registration:	10/07/2008
Prospective Registration:	Yes
Primary sponsor:	Pfizer Limited, Ramsgate Road, Sandwich, Kent
Public title:
Scientific title:	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 -
Date of first enrolment:	20/08/2008
Target sample size:	215
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001566-90
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Austria	Belgium	Czech Republic	Denmark	Finland	France	Germany	Greece
Italy	Lithuania	Netherlands	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. 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.
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.
? 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.
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:
? Known hypersensitivity to the active ingredient in dalteparin or to any of the
excipients of this product.
? History of confirmed or suspected immunologically mediated heparin induced
thrombocytopenia.
? Severe hypertension.
? Acute gastroduodenal ulcer, cerebral hemorrhage or known hemorrhagic diathesis.
? Subacute endocarditis.
? 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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetic Foot Ulcer
MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer

Intervention(s)

Trade Name: Fragmin
Pharmaceutical Form: Injection*
INN or Proposed INN: Dalteparin sodium
CAS Number: 9041-08-1
Current Sponsor code: PNU-180524E
Other descriptive name: Fragmin
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 5000 IU/0.2-

Primary Outcome(s)

Primary end point(s): ? The number of all hemorrhages (this includes minor and major).
? The number of major hemorrhages.
? The number of minor hemorrhages.
? The number of clinically relevant minor hemorrhages.
? The number of minor trivial hemorrhages.
? Incidence, severity, and relatedness to treatment of all reported and treatment emergent adverse events and withdrawals from the trial due to adverse events.

Secondary Objective: Evaluating the number of diabetic patients with chronic neuroischaemic foot ulcers who have improved ulcers at baseline that develop intact skin healing.

Main Objective: 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.

Secondary Outcome(s)

Secondary ID(s)

2008-001566-90-GB

A6301086

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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