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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Fragmin

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcers Neuroischaemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Active study treatment

Outcomes

Primary Outcome Measures

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.

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).

Number of Minor Hemorrhages

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

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.

Number of Trivial Hemorrhages

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Secondary Outcome Measures

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.

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.

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.

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.

Time to First Amputation

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.

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.

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).

Full Information

NCT ID

NCT00765063

First Posted

September 30, 2008

Last Updated

December 1, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00765063

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcers Neuroischaemic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Active study treatment

Intervention Type

Drug

Intervention Name(s)

Fragmin

Other Intervention Name(s)

Dalteparin sodium

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of All Hemorrhages

Description

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)

Title

Number of Major Hemorrhages

Description

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

Title

Number of Minor Hemorrhages

Description

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

Time Frame

Baseline to Week 24 (EOT) or ET

Title

Number of Clinically Relevant Minor Hemorrhages

Description

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

Title

Number of Trivial Hemorrhages

Description

Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.

Time Frame

Baseline to Week 24 (EOT) or ET

Secondary Outcome Measure Information:

Title

Number of Participants With Intact Skin Healing

Description

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.

Time Frame