[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biotechnology Institute IMASD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100589329","phase-4-efficacy-of-plasma-rich-in-growth-factors-prgf-in-the-treatment-of-foot-ulcers-in-diabetic-patients-with-peripheral-arterial-disease-100589329",false,"NCT06952998","Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease","Randomized Clinical Trial, Controlled With Conventional Treatment to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease","PIEDIABETICO","Inclusion Criteria:\n\n* Patients aged at least 18 years\n* Diagnosis of type 1 or 2 diabetes\n* Presence of one or more ulcers below the malleoli\n* Ulcer size ranging from 1 to 25 cm2\n* Peripheral Arterial Disease (PAD)\n* Meet at least 2 of the following crieria:\n* Absence of peripheral pulses at any level on physical examination of lower extremities\n* Ankle pressure of 50-90 mmHg\n* Finger pressure 30-70 mmHg\n* Ankle-branchial index (ABI) 0.5-0.9\n* Finger-arm index (FIBI) 0.3-0.7\n* Transcutaneous oxygen pressure (TcPO2) 30-59 mmHg\n* Degree of infection of the lesion on IDSA\u002FIWGDF scale not greater than 1\n* Availability of observation during the study period\n* Properly completed patient informed consent\n\nExclusion Criteria:\n\n* Ulcers grade 3 or higher\n* Positive markers for HCV, AfHBs, HIV-I\u002FII or TP\n* Diabetes mellitus with poor metabolic control (evidence of glycosylated hemoglobin \\>9%)\n* Active systemic infection\n* History of cancerous or precancerous lesions in the area of intervention\n* On active treatment with other local treatment at the site of treatment\n* On active treatment with immunosuppressants and\u002For other drugs contraindicating blood collection\n* History of allergy to blood derivatives\n* Previous diagnosis of coagulopathies\n* Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of the use of acetylsalicilic acid)\n* Pregnancy or women of chilbearig age not taking effective contraceptive measures. These methods are, according to recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following Hormonal contraception associated with ovulation inhibition, intrauterine decide (IUD), intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy partner, sexual abstinence\n* Breastfeeding women\n* Treatment with monoclonal antibodies\n* Any inabilities to participate in the study","ALL","18 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease. The goal is to assess how well PRGF promotes healing over a six-month period.",[27],"Foot Ulcers, Diabetic","RECRUITING","2025-09-10",{"date":31,"type":32},"2025-09-11","ACTUAL",{"date":34,"type":21},"2025-11-01",{"date":36,"type":21},"2027-05-30",{"name":38,"class":39},"Biotechnology Institute IMASD","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100571041","phase-4-prgf-endoret-infiltrations-in-the-treatment-of-low-back-pain-100571041","NCT06715085","PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.","Multicenter, Randomized, Single-blind, Controlled Clinical Trial to Evaluate the Safety and Efficacy of PRGF-ENDORET® Infiltrations in the Treatment of Low Back Pain.","Inclusion Criteria:\n\n* Patients of legal age (≥18 years).\n* Patients diagnosed by Magnetic Resonance Imaging (MRI) with lumbar intervertebral disc degeneration(s) (Pfirrmann Scale \\> 1).Patients with positive signs in MRI at L4-L5 and\u002For L5-S1 levels, including rupture of the annulus fibrosus, annular fissure, with or without disc herniation in its protrusion form will be included.\n* Patients with low back pain with symptoms of low back pain for at least 3 months of evolution that has not responded to drug treatment.\n* Numerical pain scale (COMI PAIN SCORE): between 6 and 10, average of the last month.\n* Availability of an MRI performed in the last six months to allow the diagnosis.\n* Availability of a complete blood test (hemogram, basic biochemistry and coagulation tests) performed in the last two months.\n* Signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication.\n\nExclusion Criteria:\n\n* Patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded.\n* Patients with severe discopathies at levels adjacent to L4-L5 and\u002For L5-S1.\n* Patients who have previously undergone spinal surgery.\n* Patients who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis.\n* Patients with neurogenic motor claudication.\n* Patients with severe cardiovascular diseases, central nervous system diseases, epilepsy, coagulopathies, immunological diseases, infectious diseases (e.g. Hepatitis B and C, HIV, Syphilis), cancer or neurodegenerative pathologies.\n* Patients with a history of drug use (e.g. alcoholism or others) and mental illness or marked psychological conditions related to pain.\n* Morbidly obese patients (BMI \\> 40 kg\u002Fm2).\n* Women who are pregnant or breastfeeding or women of childbearing age who are not taking effective contraceptive measures as outlined in the Clinical Trials Facilitation and Coordination Group (CTFG) \"Recommendations Regarding Contraception and Pregnancy Testing in Clinical Trials\" V 1.1.\n* Patients with pathologies that produce marked alterations in the efficacy of PRGF or coagulation, such as, for example: poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemia with Hb \\\u003C 9), being subjected to immunosuppressive and\u002For dicoumarinic treatments, or any treatment with systemic corticosteroids during the 6 months prior to inclusion in the study\n* Patients who present allergy to any component of the sedation or to the corticoid.\n* Patients who have received previous back treatment with PRGF in the last 6 months.",{"count":49,"type":21},48,[24],"The goal of this clinical trial is to evaluate the efficacy of PRGF in reducing pain and improving patients' quality of life. Researchers will compare an experimental drug (Plasma Rich in Growth Factors) to a control corticosteroid solution in saline solution.",[53],"Diseases [C] - Musculoskeletal Diseases [C05","2025-02-04",{"date":56,"type":32},"2025-02-06",{"date":58,"type":32},"2025-01-23",{"date":60,"type":21},"2027-02-01",{"name":38,"class":39},""]