[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474945":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":66,"collaborators":26,"id":68,"slug":26,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Guna S.p.a","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MD-Tissue Medical Device","EXPERIMENTAL","Group A which, alongside physiotherapy (eccentric strengthening protocol) will receive MD-Tissue Collagen Medical Device.",[13,14],"Device: MD-Tissue Collagen Medical Device","Other: eccentric strengthening protocol",{"label":16,"type":17,"description":18,"interventionNames":19},"Eccentric strengthening protocol","OTHER","Group B who will only perform physiotherapy (eccentric strengthening protocol).",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MD-Tissue Collagen Medical Device","MD-Tissue (GUNA, Milan-Italy) Composition per 2 ml: collagen 100 micrograms Excipients: Ascorbic acid, Magnesium gluconate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, NaCl, Water for injection.\n\nSubjects will be treated with No. 6 peri-tendon injections (2 infiltrations per week for three weeks).",[9],null,{"type":17,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"eccentric strengthening protocol","Group B which, will implement only physiotherapy (eccentric strengthening protocol)",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Paoloni PM Marco, Prof","U.O.C. Medicina Fisica e Riabilitativa dell'AOU \"Policlinico Umberto I°\" Piazzale Aldo Moro, 5 00185 Roma","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Miranda MV Vincenzo, Dr","CONTACT","3351311917","+39","v.miranda@guna.it",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Laarej Kamilia, Dr","0228018359","k.laarej@guna.it",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"U.O.C. Medicina Fisica e Riabilitativa dell'AOU \"Policlinico Umberto I°\"","RECRUITING","Roma","RO","00185","Italy",{"type":56,"coordinates":57},"Point",[58,59],11.10642,44.99364,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":64,"phoneExt":41,"email":65},"Paoloni PM Marco, Prof.","3498434651","marco.paoloni@uniroma1.it",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100474945",false,"NCT05464498","Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.","Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.","AKITENMED","Inclusion Criteria:\n\n* Male and female subjects aged 18 to 70 years;\n* Subjects with tendon pain for not more than 24 weeks;\n* Subjects with clinically diagnosed and ultrasonographically confirmed insertional\u002Fnoninsertional\u002Fmystic tendinopathy;\n* Subjects with a VISA A score between 50 and 75;\n* VAS ≥ 5;\n* Subjects able to understand and answer the SF12 questionnaire;\n* Subjects able to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* subjects who have had surgery in the investigated area or lower extremity;\n* subjects who have previously undergone physiotherapy.\n* subjects with autoimmune diseases;\n* subjects with peripheral neuropathy;\n* subjects with calcific tendinopathy\n* subjects with pain of direct traumatic origin;\n* subjects with local\u002Fsystemic infections;\n* subjects with neoplastic diseases;\n* subjects with gout;\n* subjects on corticosteroid treatment at the time of enrollment;\n* subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment;\n* subjects who have used NSAIDs in the week prior to enrollment;\n* subjects who are pregnant and lactating;\n* subjects with contraindications to acetaminophen use;\n* allergy to porcine collagen.","ALL","18 Years","70 Years",{"count":79,"type":80},72,"ESTIMATED","INTERVENTIONAL",[83],"NA","Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Insertional tendinitis involves the lower part of the tendon, where the tendon inserts at the level of the calcaneus, and can affect even patients who are not particularly athletically active. Noninsertional tendinitis occurs when the fibers in the middle portion of the tendon are affected, affects young and athletic people the most, and has a high incidence (30-50%) in middle-aged individuals.\n\nConsidering that there are no strong evidence-based guidelines in the area of treatment of achilles tendinopathy, the aim of this research project is to understand through a multicenter, randomized clinical investigation the impact of treatment with a porcine collagen-based medical device administered in the peri-tendon area in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.",[86,87,88,89],"Tendinopathy","Insertional Achilles Tendinopathy","Achilles Tendinopathy","Peritendinitis",[91,92,93,94,95,96,16,97,98,99],"Eccentric strengthening","Collagene Medical Device","Physiotherapy","Peritendinous area","Infiltration","Type I collagen","Pain Visual Analog Scale","12-Item Short Form Survey","Victorian Institute of Sport Assessment- Achilles questionnaire","2025-08-01",{"date":102,"type":103},"2025-08-03","ACTUAL",{"date":105,"type":103},"2022-06-13",{"date":107,"type":80},"2026-01-13",{"name":5,"class":6},1]