Ensayo Clínico para estudiar la validez y seguridad del plasma rico en plaquetas en úlceras de extremidades inferiores.
- Conditions
- lcer that does not heal after being administered the optimal basic care after a period of six weeks.MedDRA version: 19.1Level: PTClassification code 10050502Term: Neuropathic ulcerSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 19.1Level: PTClassification code 10012679Term: Diabetic neuropathic ulcerSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 19.1Level: HLTClassification code 10040796Term: Skin and subcutaneous tissue ulcerationsSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002836-42-ES
- Lead Sponsor
- Asociación Instituto de Investigación Sanitaria BioCruces
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the safety and feasibility of the application of Platelet Rich Plasma in Chronic ulcers with difficult to heal lower extremity.;Secondary Objective: Assess the feasibility of the treatment at the Cruces University Hospital (OSI EEC).<br>Get the complete closure of 80% of treated lesions or reducing the area of the lesion in 50% of the surface.<br>Time it takes to heal the injury.<br>Evaluate the quality of life of patients using the SF-36 index at baseline and at study end.;Primary end point(s): Feasibility: The feasibility of treatment with PRP in the service Home Hospitalization at Cruces University Hospital.<br>Security:<br>- Incidence and severity of adverse reactions.<br>- Incidence and severity of other unwanted reactions.;Timepoint(s) of evaluation of this end point: One year.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): By the secondary endpoints will attempt to collect the efficacy variables.<br>Effectiveness: evaluation criteria of response in the trial:<br>- Percentage of patients with complete wound closure at 12 weeks of initiation of treatment with PRP.<br>- Percentage of patients with improvement in quality of life at 14 weeks of initiation of treatment with PRP.;Timepoint(s) of evaluation of this end point: One year.