The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

Diabetic Foot Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765063
• Other study ID #: A6301086
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 30, 2008
• Last updated: December 1, 2011
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Ransart
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czech Republic	Pfizer Investigational Site	Praha 5
Czech Republic	Pfizer Investigational Site	Zlin
Denmark	Pfizer Investigational Site	Aarhus C
Germany	Pfizer Investigational Site	Karlsbad
Greece	Pfizer Investigational Site	Melissia/Athens
Italy	Pfizer Investigational Site	Firenze
Norway	Pfizer Investigational Site	Tonsberg
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Pulawy
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Russian Federation	Pfizer Investigational Site	Moscow	Russia
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Sweden	Pfizer Investigational Site	Karlstad
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
United Kingdom	Pfizer Investigational Site	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  Germany,  Greece,  Italy,  Norway,  Poland,  Russian Federation,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of All Hemorrhages	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.	Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)	Yes
Primary	Number of Major Hemorrhages	Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).	Baseline to Week 24 (EOT) or ET	Yes
Primary	Number of Minor Hemorrhages	Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.	Baseline to Week 24 (EOT) or ET	Yes
Primary	Number of Clinically Relevant Minor Hemorrhages	Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.	Baseline to Week 24 (EOT) or ET	Yes
Primary	Number of Trivial Hemorrhages	Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.	Baseline to Week 24 (EOT) or ET	Yes
Secondary	Number of Participants With Intact Skin Healing	Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.	Baseline through Week 24 (EOT) or ET	No
Secondary	Number of Participants With Improved Ulcer Healing	Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.	Baseline through Week 24 (EOT) or ET	No
Secondary	Number of Participants Who Underwent Amputation	A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.	Baseline through Week 24 (EOT) or ET	No
Secondary	Time to Intact Skin Healing	Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.	Baseline through Week 24 (EOT) or ET	No
Secondary	Time to First Amputation		Baseline through Week 24 (EOT) or ET	No
Secondary	Number of Participants With Major Cardiovascular Disease Events (MCVE)	MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.	Baseline through Week 24 (EOT) or ET	Yes
Secondary	11-point Likert Pain Scale	The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.	Baseline and Week 24 (EOT) or ET	No
Secondary	36-Item Short-Form Health Survey (SF-36) Score	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline and Week 24 (EOT) or ET	No

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