At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 62 enrolled
Drug / intervention
Fragmindrug
Likely dose
Fragmin 5000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fragmin for Diabetic Foot Ulcer. Completed, enrolled 62 participants across 27 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesAustria, Belgium, Canada, Czechia, Denmark, Germany, Greece, Italy, Norway, Poland, Russia, Sweden, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionOct 2010
TodayJul 2026
First PostedOct 2, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.8 years ago
Interventions
Fragmindrug
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium