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

NCT00765063 | Completed Phase 2 Results

• 1 other identifier: A6301086
• Study Type: interventional
• Target: 62
• Locations: 14 countries
• Sites: 27

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcers Neuroischaemic

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)

• 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).

  Baseline to Week 24 (EOT) or ET

• Number of Minor Hemorrhages

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

  Baseline to Week 24 (EOT) or ET

• 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.

  Baseline to Week 24 (EOT) or ET

• Number of Trivial Hemorrhages

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

  Baseline to Week 24 (EOT) or ET

Secondary Outcomes (8)

• Number of Participants With Intact Skin Healing

  Baseline through Week 24 (EOT) or ET

• Number of Participants With Improved Ulcer Healing

  Baseline through Week 24 (EOT) or ET

• Number of Participants Who Underwent Amputation

  Baseline through Week 24 (EOT) or ET

• Time to Intact Skin Healing

  Baseline through Week 24 (EOT) or ET

• Time to First Amputation

  Baseline through Week 24 (EOT) or ET

Study Arms (1)

Active

EXPERIMENTAL

Active study treatment

Drug: Fragmin

Interventions

Fragmin DRUG

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

Also known as: Dalteparin sodium

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (27)

Pfizer Investigational Site

Vienna, A-1090, Austria

Location

Pfizer Investigational Site

Ransart, 6043, Belgium

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Prague, 150 06, Czechia

Location

Pfizer Investigational Site

Zlín, 760 01, Czechia

Location

Pfizer Investigational Site

Aarhus C, 8000, Denmark

Location

Pfizer Investigational Site

Karlsbad, 76307, Germany

Location

Pfizer Investigational Site

Melissia/Athens, 15127, Greece

Location

Pfizer Investigational Site

Florence, 50139, Italy

Location

Pfizer Investigational Site

Tønsberg, 3103, Norway

Location

Pfizer Investigational Site

Lodz, 90-153, Poland

Location

Pfizer Investigational Site

Puławy, 24-100, Poland

Location

Pfizer Investigational Site

Warsaw, 02-097, Poland

Location

Pfizer Investigational Site

Wroclaw, 51-124, Poland

Location

Pfizer Investigational Site

Moscow, Russia, 119034, Russia

Location

Pfizer Investigational Site

Moscow, 123423, Russia

Location

Pfizer Investigational Site

Moscow, 127486, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194156, Russia

Location

Pfizer Investigational Site

Karlstad, 651 85, Sweden

Location

Pfizer Investigational Site

Malmo, 205 02, Sweden

Location

Pfizer Investigational Site

Stockholm, 118 83, Sweden

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Pfizer Investigational Site

Stockholm, 182 88, Sweden

Location

Pfizer Investigational Site

Kharkiv, 61002, Ukraine

Location

Pfizer Investigational Site

Kyiv, 02091, Ukraine

Location

Pfizer Investigational Site

Lviv, 79010, Ukraine

Location

Pfizer Investigational Site

Birmingham, B9 5SS, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetic Foot

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Study enrollment was terminated before planned number of participants was obtained. Although randomized participants were allowed to complete entire course of therapy according to protocol and study status was therefore designated as completed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 13, 2012
• Results First Posted: January 13, 2012

Record last verified: 2011-12

Locations

AU (1); CA (1); IT (1); SE (5); GR (1); PL (4); UA (3); GB (1); BE (1); DE (1); RU (4); CZ (2); NO (1); DK (1)