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

Pfizer62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

FragminDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Pfizer Investigational Site

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)

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).

Time frame: Baseline to Week 24 (EOT) or ET

Number of Minor Hemorrhages

Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

Time frame: Baseline to Week 24 (EOT) or ET

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.

Time frame: Baseline to Week 24 (EOT) or ET

Number of Trivial Hemorrhages

Data from ClinicalTrials.gov

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Secondary Outcomes

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.