At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 276 enrolled
Drug / intervention
Fragmin/ Dalteparin Sodium +1 moredrug
Likely dose
Fragmin/ Dalteparin Sodium 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, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients
In Brief
A Phase 3 clinical trial evaluating Fragmin/ Dalteparin Sodium and Placebo for Fragmin/ Dalteparin Sodium for Diabetic Foot Ulcer. Completed, enrolled 276 participants across 63 sites in 17 countries.
Detailed Summary
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesAustria, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Italy, Lithuania, Norway, Poland, Russia, Spain, Sweden, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionOct 2010
TodayJul 2026
First PostedApr 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.2 years ago
Interventions
Fragmin/ Dalteparin Sodiumdrug
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
Placebo for Fragmin/ Dalteparin Sodiumdrug
Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.