[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-neuropathies-painful\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-neuropathies-painful":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100612982","early-phase-1-efficacy-of-a-topical-palmitated-formulation-of-capsaicin-capsadyn-in-the-treatment-of-diabetic-neuropathic-foot-pain-100612982",false,"NCT07260656","Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain","A Double-Blind, Randomized, Pilot Study to Investigate the Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain","Inclusion Criteria:\n\n* At least 3 toes per foot\n* Have otherwise intact feet.\n* Absence of any eczema, hyperkeratosis, scleroderma, or other dermatological conditions afflicting the area of Test Article administration that may interfere with absorption, particularly hyperhidrosis.\n* Must agree to apply the Test Article to painful areas of feet as directed by research personnel.\n* Must agree to apply the Test Article to feet as instructed 2x per day.\n* Must wait 60 minutes after each application of Test Article before filling out NRS forms.\n* Unless burning is encountered soon after application, the participant must wait at least 60 minutes before washing feet after application of Test Article.\n* All participants must be willing to use Test Articles blinded.\n\nExclusion Criteria:\n\n* Younger than 25 and older than 75 years of age\n* Any dermatological condition(s) with the potential to disrupt skin integrity or alter sensory function of the feet.\n* Any open wounds, skin ulceration, infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) affecting the feet within 30 days.\n* Any recent medical history of surgery affecting the feet.\n* Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams\u002Flotions\u002Fpatches\u002Fgels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited.\n* Current substance abuse.\n* History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil.\n* Except for interventions for mobility, (e.g., physical therapy, exercise, grounding) no concurrent foot therapy for pain that may interfere with NRS evaluations is permitted (e.g., massage, electrophoresis, red light, etc.).\n* No concurrent enrollment in another clinical trial.","ALL","25 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.",[27,28,29],"Diabetic Neuropathies, Painful","Diabetic Foot","Diabetic Peripheral Neuropathy",[31],"diabetic foot pain","RECRUITING","2026-04-15",{"date":35,"type":36},"2026-04-20","ACTUAL",{"date":38,"type":36},"2025-11-26",{"date":40,"type":21},"2027-11",{"name":42,"class":43},"Carilion Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100621960","beneficial-effects-of-supplementation-with-cronilief-palmitoylethanolamide-phospholipids-in-diabetic-subjects-with-neuropathic-pain-100621960","NCT07377409","Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.","Randomised, Placebo-controlled Study to Evaluate the Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids), in Addition to Standard Therapy, in Diabetic Subjects With Neuropathic Pain.","Inclusion Criteria:\n\n* Satisfactory metabolic compensation;\n* Presence of moderate symptoms of painful diabetic neuropathy as assessed by the LANSS questionnaire (score ≥12);\n* Taking antidiabetic drugs except insulin;\n* Subjects willing and able to comply with scheduled study visits, the treatment plan, and all procedures outlined in the study.\n\nExclusion Criteria:\n\n* Previous intolerance to a component of the nutraceuticals tested;\n* Individuals with type I diabetes;\n* Uncontrolled diabetes, severe cardiovascular and cerebrovascular diseases;\n* Severe neuropathic symptoms as indicated by the LANSS score;\n* Individuals undergoing insulin treatment;\n* Peripheral neuropathy due to diseases other than diabetes mellitus;\n* History of malignant neoplasm in the 5 years prior to enrolment in the study;\n* Serious neurological, psychological or psychiatric disorders;\n* Clinical signs or history of significant impairment of hepatic or renal function, peptic ulcer or coagulation disorders;\n* Any clinically relevant or unstable disease (e.g., active malignancies, immune system disorders) whose sequelae or treatments could contraindicate participation in the study or interfere with the study's evaluation parameters, in the investigator's judgement; Any disease that could significantly affect the study's outcome, including, but not limited to, chronic medical conditions, psychological disorders, or substance abuse;\n* Alcohol or drug abuse;\n* Women of childbearing age who do not use established contraceptive methods;\n* Pregnancy and breastfeeding.","18 Years","65 Years",{"count":55,"type":21},70,[57],"NA","This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.",[60,27,61],"Neuropathic Pain Management","Palmitoylethanolamide","NOT_YET_RECRUITING","2026-02-12",{"date":65,"type":36},"2026-02-17",{"date":67,"type":21},"2026-09-15",{"date":69,"type":21},"2027-01-15",{"name":71,"class":43},"Azienda di Servizi alla Persona di Pavia"]