- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00765063
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
1 de diciembre de 2011 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
62
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Karlsbad, Alemania, 76307
- Pfizer Investigational Site
-
-
-
-
-
Wien, Austria, A-1090
- Pfizer Investigational Site
-
-
-
-
-
Ransart, Bélgica, 6043
- Pfizer Investigational Site
-
-
-
-
Manitoba
-
Winnipeg, Manitoba, Canadá, R3A 1R9
- Pfizer Investigational Site
-
-
-
-
-
Aarhus C, Dinamarca, 8000
- Pfizer Investigational Site
-
-
-
-
-
Moscow, Federación Rusa, 123423
- Pfizer Investigational Site
-
Moscow, Federación Rusa, 127486
- Pfizer Investigational Site
-
Saint-Petersburg, Federación Rusa, 194156
- Pfizer Investigational Site
-
-
Russia
-
Moscow, Russia, Federación Rusa, 119034
- Pfizer Investigational Site
-
-
-
-
-
Melissia/Athens, Grecia, 15127
- Pfizer Investigational Site
-
-
-
-
-
Firenze, Italia, 50139
- Pfizer Investigational Site
-
-
-
-
-
Tonsberg, Noruega, 3103
- Pfizer Investigational Site
-
-
-
-
-
Lodz, Polonia, 90-153
- Pfizer Investigational Site
-
Pulawy, Polonia, 24-100
- Pfizer Investigational Site
-
Warszawa, Polonia, 02-097
- Pfizer Investigational Site
-
Wroclaw, Polonia, 51-124
- Pfizer Investigational Site
-
-
-
-
-
Birmingham, Reino Unido, B9 5SS
- Pfizer Investigational Site
-
-
-
-
-
Praha 5, República Checa, 150 06
- Pfizer Investigational Site
-
Zlin, República Checa, 760 01
- Pfizer Investigational Site
-
-
-
-
-
Karlstad, Suecia, 651 85
- Pfizer Investigational Site
-
Malmo, Suecia, 205 02
- Pfizer Investigational Site
-
Stockholm, Suecia, 118 83
- Pfizer Investigational Site
-
Stockholm, Suecia, 171 76
- Pfizer Investigational Site
-
Stockholm, Suecia, 182 88
- Pfizer Investigational Site
-
-
-
-
-
Kharkiv, Ucrania, 61002
- Pfizer Investigational Site
-
Kyiv, Ucrania, 02091
- Pfizer Investigational Site
-
Lviv, Ucrania, 79010
- Pfizer Investigational Site
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Activo
Tratamiento de estudio activo
|
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of All Hemorrhages
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Intact Skin Healing
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline through Week 24 (EOT) or ET
|
Baseline through Week 24 (EOT) or ET
|
|
Number of Participants With Major Cardiovascular Disease Events (MCVE)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2008
Finalización primaria (Actual)
1 de octubre de 2010
Finalización del estudio (Actual)
1 de octubre de 2010
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2008
Publicado por primera vez (Estimar)
2 de octubre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de enero de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
1 de diciembre de 2011
Última verificación
1 de diciembre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de la piel
- Enfermedades del sistema endocrino
- Angiopatías diabéticas
- Úlcera en la pierna
- Úlcera de la piel
- Complicaciones de la diabetes
- Diabetes mellitus
- Neuropatías diabéticas
- Enfermedades de los pies
- Pie diabético
- Úlcera del pie
- Úlcera
- Mecanismos moleculares de acción farmacológica
- Agentes fibrinolíticos
- Agentes moduladores de fibrina
- Anticoagulantes
- Dalteparina
Otros números de identificación del estudio
- A6301086
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Fragmin
-
University Hospital, Basel, SwitzerlandTerminado
-
PfizerTerminadoTrombosis venosa profunda aguda
-
PfizerTerminadoÚlcera de pie diabéticoCanadá, Grecia, Austria, Finlandia, Polonia, Suecia, Federación Rusa, Noruega, España, Italia, Reino Unido, Dinamarca, Lituania, Bélgica, Alemania, Ucrania, Chequia
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Australian and New Zealand Intensive... y otros colaboradoresTerminadoEnfermedad crítica | Trombosis venosa profundaEstados Unidos, Australia, Canadá, Arabia Saudita, Brasil, Reino Unido
-
Jonsson Comprehensive Cancer CenterUpjohnTerminadoLinfoma | Cáncer de cuello uterino | Síndromes mielodisplásicos | Leucemia | Trastornos mieloproliferativos crónicos | Tumor sólido adulto no especificado, protocolo específico | Mieloma múltiple y neoplasia de células plasmáticas | Condición precancerosa/no maligna | Enfermedad venooclusivaEstados Unidos
-
Anthos Therapeutics, Inc.ItreasReclutamientoTromboembolismo venoso | Embolia pulmonar | Trombosis venosa profundaAustria, Estados Unidos, Taiwán, Australia, España, Corea, república de, Italia, Hungría, Francia, Países Bajos, Canadá, Letonia, Alemania, Reino Unido, Noruega, Suecia, Irlanda, Chequia, Suiza
-
M.D. Anderson Cancer CenterBrookdale University Hospital Medical Center; Josephine Ford Cancer CenterTerminadoNeoplasias | La trombosis venosa profundaEstados Unidos
-
Martina Hansen's HospitalOslo University HospitalTerminadoInfección | Artritis de la cadera | Complicaciones relacionadas con transfusiones | Wound DischargeNoruega
-
University Medical Centre LjubljanaTerminadoTromboflebitis superficialEslovenia