Ulcer that does not heal after being administered the optimal basic care after a period of six weeks. MedDRA version: 19.1 Level: PT Classification code 10050502 Term: Neuropathic ulcer System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.1 Level: PT Classification code 10012679 Term: Diabetic neuropathic ulcer System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.1 Level: HLT Classification code 10040796 Term: Skin and su
Conditions
Interventions
Product Name: Platelet Rich Plasma
Product Code: PRP
Pharmaceutical Form: Cutaneous paste
INN or Proposed INN: PRP
Other descriptive name: AUTOLOGOUS PLASMA
Concentration unit: Ci/µl curie(s)/microlit
Sponsors
Asociación Instituto de Investigación Sanitaria BioCruces
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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.;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.;Timepoint(s) of evaluation of this end point: One year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: One year. | — |
Countries
Spain
Contacts
Public ContactBioCruces
Asociación Instituto Investigación Sanitaria BioCruces
Outcome results
None listed