Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

NCT00662831 | Completed Phase 2 Results DMC

• 1 other identifier: A6301083
• Study Type: interventional
• Target: 276
• Locations: 17 countries
• Sites: 63

Brief 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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcers Neuroischaemic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing

  University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure\>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure\<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure\>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure\<=30 mmHg and UT grade and stage 2C.

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

Secondary Outcomes (13)

• Number of Participants With Intact Skin Healing

  Week 24 (EOT) or early termination

• Number of Participants Who Underwent Any Amputation

  Week 24 (EOT) or early termination

• Number of Participants Who Underwent Major and Minor Amputation

  Week 24 (EOT) or early termination

• Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing

  Week 24 (EOT) or early termination

• Number of Participants Who Died

  Week 24 (EOT) or early termination

Other Outcomes (3)

• Number of All Hemorrhages

  Week 24 (EOT) or early termination

• Number of Major and Minor Hemorrhages

  Week 24 (EOT) or early termination

• Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages

  Week 24 (EOT) or early termination

Study Arms (2)

Active

EXPERIMENTAL

Active study treatment

Drug: Fragmin/ Dalteparin Sodium

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo for Fragmin/ Dalteparin Sodium

Interventions

Fragmin/ Dalteparin Sodium DRUG

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

Active

Placebo for Fragmin/ Dalteparin Sodium DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects 18 years of age with type 1 or type 2 diabetes.
• Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of \>3

You may not qualify if:

• Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
• Subjects with a known bleeding disorder or evidence of active bleeding.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (63)

Pfizer Investigational Site

Klagenfurt, A-9020, Austria

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Vienna, A-1030, Austria

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Vienna, A-1090, Austria

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Ransart, 6043, Belgium

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Winnipeg, Manitoba, R3A 1R9, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Prague, 140 21, Czechia

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Prague, 150 06, Czechia

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Zlín, 760 01, Czechia

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Aalborg, 9100, Denmark

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Aarhus C, 8000, Denmark

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Hvidovre, 2650, Denmark

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Koebenhavn NV, 2400, Denmark

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Odense C, 5000, Denmark

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Sønderborg, 6400, Denmark

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Tampere, 33520, Finland

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Karlsbad, 76307, Germany

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Athens, 106 76, Greece

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Athens, 11527, Greece

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Melissia/Athens, 15127, Greece

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Thessaloniki, 56429, Greece

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San Giovanni Rotondo, FG, 71013, Italy

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Florence, 50139, Italy

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Pisa, 56124, Italy

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Roma, 00133, Italy

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Kaunas, 49476, Lithuania

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Vilnius, 01102, Lithuania

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Vilnius, 10207, Lithuania

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Tønsberg, 3103, Norway

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Gdansk, 80-952, Poland

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Lodz, 90-153, Poland

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Puławy, 24-100, Poland

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Warsaw, 02-097, Poland

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Wroclaw, 51-124, Poland

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Moscow, 109240, Russia

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Moscow, 115998, Russia

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Moscow, 119034, Russia

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Moscow, 123423, Russia

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Moscow, 127486, Russia

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Saint Petersburg, 194156, Russia

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Getafe, Madrid, 28905, Spain

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Girona, 17007, Spain

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Madrid, 28040, Spain

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Karlstad, 651 85, Sweden

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Malmo, 205 02, Sweden

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Stockholm, 11883, Sweden

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Stockholm, 141 86, Sweden

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Stockholm, 17176, Sweden

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Stockholm, 182 88, Sweden

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Stockholm, 18288, Sweden

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Kharkiv, 61002, Ukraine

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Kyiv, 02091, Ukraine

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Lviv, 79010, Ukraine

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Odesa, 65009, Ukraine

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Barnsley, S75 2EP, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Colchester, CO4 5JL, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Ipswich, IP4 5PD, United Kingdom

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Manchester, M13 0JE, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Peterborough, PE3 9GZ, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 19, 2018
• Results First Posted: January 13, 2012

Record last verified: 2018-11

Locations

IT (4); RU (6); UA (4); DK (6); CZ (3); CA (2); GR (4); NO (1); SE (7); ES (3); LI (3); FI (1); AU (3); BE (1); PL (5); DE (1); GB (9)