E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcer that does not heal after being administered the optimal basic care after a period of six weeks. |
Ulcera que no cicatriza tras habérsele administrado los cuidados básicos óptimos después de un plazo de 6 semanas, úlcera de difícil cicatrización. |
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E.1.1.1 | Medical condition in easily understood language |
Ulcers that not cure with standard therapy. |
Ulceras que no curan con tratamiento habitual. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050502 |
E.1.2 | Term | Neuropathic ulcer |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012679 |
E.1.2 | Term | Diabetic neuropathic ulcer |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10040796 |
E.1.2 | Term | Skin and subcutaneous tissue ulcerations |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine the safety and feasibility of the application of Platelet Rich Plasma in Chronic ulcers with difficult to heal lower extremity. |
Evaluar la seguridad de la aplicación de PRP en heridas crónicas de extremidades inferiores (EEII) de difícil cicatrización. |
|
E.2.2 | Secondary objectives of the trial |
Assess the feasibility of the treatment at the Cruces University Hospital (OSI EEC). Get the complete closure of 80% of treated lesions or reducing the area of the lesion in 50% of the surface. Time it takes to heal the injury. Evaluate the quality of life of patients using the SF-36 index at baseline and at study end. |
Evaluar la factibilidad del tratamiento en el Hospital Universitario Cruces (OSI EEC). Conseguir el cierre completo del 80% de las lesiones tratadas o la reducción del área de la lesión en el 50% de la superficie. Tiempo que tarda en cicatrizar la lesión. Evaluar la calidad de vida de los pacientes utilizando el índice SF-36 en el momento basal y al finalizar el estudio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who have been treated in the coverage area of the OSI EEC. - Age ≥ 18 years. - Ulcer below the knee of more than 6 weeks of evolution has received conventional treatment. - ABI ≥ 0.7 or otherwise positive distal pulses. Subjects were considered to pulses present those people they feel is achieved, at least, pedal pulses or posterior tibial. - Signature of informed consent. - Ability to be transferred to the HUC (Home Care Service). - Women of childbearing potential must have a negative test result pregnancy and accept the use of contraceptive methods while remaining in the study. |
- Pacientes que hayan sido atendidos en el área de cobertura de la OSI EEC. - Edad ≥ 18 años. - Úlcera por debajo de la rodilla de más de 6 semanas de evolución que ha recibido tratamiento convencional. - ITB ≥ 0,7 o en su defecto pulsos distales positivos. Se consideraran sujetos con pulsos presentes a aquellas personas a las cuales se consiga palpar, al menos, el pulso pedio o el tibial posterior. - Firma del consentimiento informado. - Posibilidad de ser trasladado al HUC (Servicio de Hospitalización a Domicilio). - Las mujeres en edad fértil deberán obtener un resultado negativo en el test de embarazo y aceptar el empleo de métodos anticonceptivos mientras permanezca en el estudio. |
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E.4 | Principal exclusion criteria |
- Greater contralateral limb amputation. - Pregnant or lactating women. - Clinical infection of the ulcer. - Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9 gr/dl). - Being undergoing systemic immunosuppressive treatments. - Severe heart disease diagnosed. - Patients with active cancer or diagnosed in the last 5 years cancer. - Serological diagnosis of Hepatitis B, C or HIV infection. - Patients who are taking a drug undergoing clinical research or have participated in a study phase clinical research (with a authorized or not) product. - Any physical, social or psychological problem that, in the opinion of the researchers, may affect the patient's participation in the trial or to the validity of the data obtained by participating in it. - Patients unable to comply with scheduled visits. |
- Amputación mayor de extremidad contralateral. - Mujeres embarazadas o en periodo de lactancia. - Infección clínica de la úlcera. - Alteraciones hematológicas (trombopatía, trombopenia, anemias con Hb<9 gr/dl). - Estar siendo sometido a tratamientos inmunosupresores sistémicos. - Cardiopatía severa diagnosticada. - Pacientes con cáncer activo o con cáncer diagnosticado en los últimos 5 años. - Diagnóstico serológico de Hepatitis B, C o infección VIH. - Pacientes que estén tomando un fármaco en fase de investigación clínica o hayan participado en algún estudio en fase de investigación clínica (con un producto autorizado o no). - Cualquier problema físico, social o psicológico que, en opinión de los investigadores, pueda afectar a la participación del paciente en el ensayo o a la validez de los datos obtenidos por su participación en el mismo. - Pacientes que no puedan cumplir con las visitas programadas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility: The feasibility of treatment with PRP in the service Home Hospitalization at Cruces University Hospital. Security: - Incidence and severity of adverse reactions. - Incidence and severity of other unwanted reactions. |
Factibilidad: la factibilidad del tratamiento con PRP en el Servicio de Hospitalización a domicilio del Hospital Universitario Cruces. Seguridad: - Incidencia e intensidad de reacciones adversas. - Incidencia y severidad de otras reacciones indeseadas. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
By the secondary endpoints will attempt to collect the efficacy variables. Effectiveness: evaluation criteria of response in the trial: - Percentage of patients with complete wound closure at 12 weeks of initiation of treatment with PRP. - Percentage of patients with improvement in quality of life at 14 weeks of initiation of treatment with PRP. |
Mediante las variables secundarias se tratará de recoger las variables de eficacia. Eficacia: criterios de evaluación de la respuesta en el ensayo: - Porcentaje de pacientes con cierre completo de la herida a las 12 semanas del inicio del tratamiento con PRP. - Porcentaje de pacientes con mejoría en la calidad de vida a las 14 semanas del inicio del tratamiento con PRP. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The completion of the assay correspond to the date on which it performs last visit or the last follow-up contact with the last patient recruited. It will be notified via fax or mail to the competent authorities by the Sponsor, filing a copy in the Sponsor Master File. If there is a premature suspension of the test it should also be communicated to the competent authorities. |
La finalización del ensayo corresponderá con la fecha en la que se realiza la última visita ó el último contacto de seguimiento con el último paciente reclutado. Se notificará vía fax o mail a las autoridades competentes por parte del Promotor, archivándose una copia en la Documentación del Promotor. Si existe una suspensión prematura del ensayo, deberá ser asimismo comunicado a las autoridades competentes. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |