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

Phase 2

Completed

Conditions: Diabetic Foot Ulcer

Interventions: Drug: Fragmin

Registration Number: NCT00765063

Lead Sponsor: Pfizer

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	Fragmin	Active study treatment

Primary Outcome Measures

Name	Time	Method
Number of All Hemorrhages	Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)	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.
Number of Major Hemorrhages	Baseline to Week 24 (EOT) or ET	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).
Number of Minor Hemorrhages	Baseline to Week 24 (EOT) or ET	Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Number of Clinically Relevant Minor Hemorrhages	Baseline to Week 24 (EOT) or ET	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.
Number of Trivial Hemorrhages	Baseline to Week 24 (EOT) or ET	Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Intact Skin Healing	Baseline through Week 24 (EOT) or ET	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.
Number of Participants With Improved Ulcer Healing	Baseline through Week 24 (EOT) or ET	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.
Number of Participants Who Underwent Amputation	Baseline through Week 24 (EOT) or ET	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.
Time to Intact Skin Healing	Baseline through Week 24 (EOT) or ET	Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Time to First Amputation	Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)	Baseline through Week 24 (EOT) or ET	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.
11-point Likert Pain Scale	Baseline and Week 24 (EOT) or ET	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.
36-Item Short-Form Health Survey (SF-36) Score	Baseline and Week 24 (EOT) or ET	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).