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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Active study treatment

Group Type EXPERIMENTAL

Fragmin

Intervention Type DRUG

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

Interventions

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Fragmin

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

Intervention Type DRUG

Other Intervention Names

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Dalteparin sodium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No