Clinical trial NCT00765063: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcers Neuroischaemic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of All Hemorrhages
timeFrame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
measure: Number of Major Hemorrhages
timeFrame: Baseline to Week 24 (EOT) or ET
measure: Number of Minor Hemorrhages
timeFrame: Baseline to Week 24 (EOT) or ET
measure: Number of Clinically Relevant Minor Hemorrhages
timeFrame: Baseline to Week 24 (EOT) or ET
measure: Number of Trivial Hemorrhages
timeFrame: Baseline to Week 24 (EOT) or ET
Secondary outcomes:
measure: Number of Participants With Intact Skin Healing
timeFrame: Baseline through Week 24 (EOT) or ET
measure: Number of Participants With Improved Ulcer Healing
timeFrame: Baseline through Week 24 (EOT) or ET
measure: Number of Participants Who Underwent Amputation
timeFrame: Baseline through Week 24 (EOT) or ET
measure: Time to Intact Skin Healing
timeFrame: Baseline through Week 24 (EOT) or ET
measure: Time to First Amputation
timeFrame: Baseline through Week 24 (EOT) or ET
measure: Number of Participants With Major Cardiovascular Disease Events (MCVE)
timeFrame: Baseline through Week 24 (EOT) or ET
measure: 11-point Likert Pain Scale
timeFrame: Baseline and Week 24 (EOT) or ET
measure: 36-Item Short-Form Health Survey (SF-36) Score
timeFrame: Baseline and Week 24 (EOT) or ET
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Ransart
country: Belgium
facility: Pfizer Investigational Site
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Zlin
country: Czech Republic
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Karlsbad
country: Germany
facility: Pfizer Investigational Site
city: Melissia/Athens
country: Greece
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Pulawy
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
state: Russia
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: