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

1. december 2011 opdateret af: Pfizer

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Ransart, Belgien, 6043
        • Pfizer Investigational Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
  • Danmark
      • Aarhus C, Danmark, 8000
        • Pfizer Investigational Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 123423
        • Pfizer Investigational Site
      • Moscow, Den Russiske Føderation, 127486
        • Pfizer Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 194156
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, Den Russiske Føderation, 119034
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B9 5SS
        • Pfizer Investigational Site
  • Grækenland
      • Melissia/Athens, Grækenland, 15127
        • Pfizer Investigational Site
  • Italien
      • Firenze, Italien, 50139
        • Pfizer Investigational Site
  • Norge
      • Tonsberg, Norge, 3103
        • Pfizer Investigational Site
  • Polen
      • Lodz, Polen, 90-153
        • Pfizer Investigational Site
      • Pulawy, Polen, 24-100
        • Pfizer Investigational Site
      • Warszawa, Polen, 02-097
        • Pfizer Investigational Site
      • Wroclaw, Polen, 51-124
        • Pfizer Investigational Site
  • Sverige
      • Karlstad, Sverige, 651 85
        • Pfizer Investigational Site
      • Malmo, Sverige, 205 02
        • Pfizer Investigational Site
      • Stockholm, Sverige, 118 83
        • Pfizer Investigational Site
      • Stockholm, Sverige, 171 76
        • Pfizer Investigational Site
      • Stockholm, Sverige, 182 88
        • Pfizer Investigational Site
  • Tjekkiet
      • Praha 5, Tjekkiet, 150 06
        • Pfizer Investigational Site
      • Zlin, Tjekkiet, 760 01
        • Pfizer Investigational Site
  • Tyskland
      • Karlsbad, Tyskland, 76307
        • Pfizer Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61002
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 02091
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79010
        • Pfizer Investigational Site
  • Østrig
      • Wien, Østrig, A-1090
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aktiv
Aktiv studiebehandling
Medicin: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Andre navne:
  • Dalteparinnatrium

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of All Hemorrhages
Tidsramme: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
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
Tidsramme: Baseline to Week 24 (EOT) or ET
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
Tidsramme: Baseline to Week 24 (EOT) or ET
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
Tidsramme: Baseline to Week 24 (EOT) or ET
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
Tidsramme: Baseline to Week 24 (EOT) or ET
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Intact Skin Healing
Tidsramme: Baseline through Week 24 (EOT) or ET
Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.
Baseline through Week 24 (EOT) or ET
Number of Participants With Improved Ulcer Healing
Tidsramme: Baseline through Week 24 (EOT) or ET
Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.
Baseline through Week 24 (EOT) or ET
Number of Participants Who Underwent Amputation
Tidsramme: Baseline through Week 24 (EOT) or ET
A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.
Baseline through Week 24 (EOT) or ET
Time to Intact Skin Healing
Tidsramme: Baseline through Week 24 (EOT) or ET
Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Baseline through Week 24 (EOT) or ET
Time to First Amputation
Tidsramme: Baseline through Week 24 (EOT) or ET
Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)
Tidsramme: Baseline through Week 24 (EOT) or ET
MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.
Baseline through Week 24 (EOT) or ET
11-point Likert Pain Scale
Tidsramme: Baseline and Week 24 (EOT) or ET
The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.
Baseline and Week 24 (EOT) or ET
36-Item Short-Form Health Survey (SF-36) Score
Tidsramme: Baseline and Week 24 (EOT) or ET
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Baseline and Week 24 (EOT) or ET

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2008

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

30. september 2008

Først indsendt, der opfyldte QC-kriterier

30. september 2008

Først opslået (Skøn)

2. oktober 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2011

Sidst verificeret

1. december 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6301086

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetisk fodsår

Kliniske forsøg med Fragmin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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