[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06777511":3,"trial-entities:NCT06777511":118,"trial-summary:NCT06777511":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":38,"secondary_outcomes":43,"sex":74,"minimum_age":75,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":76,"std_ages":84,"locations":87,"central_contacts":107,"overall_officials":115,"references":116,"see_also_links":117},"NCT06777511","STUDY02003108","Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients","NOT_YET_RECRUITING","2028-10","2026-07","2026-07-29","2026-10","Dartmouth-Hitchcock Medical Center","OTHER",false,"This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD.\n\nAll eligible consenting patients will undergo daily stoma management per standard of care.\n\nPatients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes.\n\nData collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes.\n\nFollow-up: Study participants will be followed at 1 week and 2 weeks.",null,[18,19],"Amputation","Osseointegration",[],"OBSERVATIONAL",[],{"count":24,"type":25},10,"ESTIMATED",[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DRUG","5-aminolevulinic acid (5-ALA)","All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device as part of their standard stoma management.",[32],"Osseointegration patients",{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Photodynamic therapy (PDT)","All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device photodynamic therapy device as part of their standard stoma management.",[32],[39],{"measure":40,"description":41,"timeFrame":42},"Feasibility","Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week\u002F2-week follow-up.","2 weeks",[44,47,50,53,56,59,62,65,68,71],{"measure":45,"description":46,"timeFrame":42},"Treatment Evaluation Inventory-Short Form (TEI-SF)","The TEI-sf is a 9-item questionnaire used to measure intervention acceptability from the participants point of view. Scores range from 9 to 45, and scores above 27 are considered acceptable.",{"measure":48,"description":49,"timeFrame":42},"System Usability Scale (SUS)","The SUS is a reliable 10-item usability measure with scores that range from 0 to 100 (an above average score is 68 or higher.",{"measure":51,"description":52,"timeFrame":42},"Bioburden quantification (16S rRNA sequencing)","Bioburden will be quantified using quantitative PCR-based assays as well as addition of a \"spikein\" of a defined quantity of bacterial cells derived from halophilic organism Salnibacter ruber.",{"measure":54,"description":55,"timeFrame":42},"Bioburden quantification (Optical Coherence Tomography (OCT)","Biofilm will be imaged and quantified on the metal abutment",{"measure":57,"description":58,"timeFrame":42},"OCT \"virtual biopsy\"","Presence of inflammation, hypergranulation, and any resulting changes (e.g., the degree of epidermal regression, dermal attachment to the implant, and epithelial layer thickness) can be quantified through morphologic analysis of the OCT B-scans. Scars are characterized by excessive collagen deposition, increased blood vessel density, and parallel blood vessel organization compared with normal skin.",{"measure":60,"description":61,"timeFrame":42},"Scar thickness","Scar thickness measured using OCT",{"measure":63,"description":64,"timeFrame":42},"Blood vessel density","Blood vessel density measuring using OCT",{"measure":66,"description":67,"timeFrame":42},"Presence of hypergranulation","Hypergranulation measured using OCT",{"measure":69,"description":70,"timeFrame":42},"Pain during light exposure","Patient reported pain during light exposure",{"measure":72,"description":73,"timeFrame":42},"Discomfort, burning, itchiness, or redness","Patient reported discomfort, burning, itchiness or redness","ALL","18 Years",{"inclusion":77,"exclusion":79,"raw_text":83},[78],"All patients with osseointegrated prostheses 18 years of age or older",[80,81,82],"Ongoing infection","Pregnant","Anticipated issues with compliance or follow-up","Inclusion Criteria:\n\n* All patients with osseointegrated prostheses 18 years of age or older\n\nExclusion Criteria:\n\n* Ongoing infection\n* Pregnant\n* Anticipated issues with compliance or follow-up",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":104},"Walter Reed National Military Medical Center","Bethesda","Maryland","20889","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Christopher H Renninger, MD","CONTACT","(202)-929-0618","christopher.h.renninger.mil@health.mil",{"name":101,"role":97,"phone":102,"email":103},"Qingfeng Liu","(240) 645-3068","Qingfeng.liu.ctr@usuhs.edu",{"lat":105,"lon":106},38.98067,-77.10026,[108,112],{"name":109,"role":97,"phone":110,"email":111},"Devin Mullin","603-650-6032","Devin.S.Mullin@hitchcock.org",{"name":113,"role":97,"phone":110,"email":114},"Ida Gitajn","Ida.Leah.Gitajn@hitchcock.org",[],[],[],{"nct_id":4,"conditions":119,"biomarkers":120},[19],[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study involving 10 participants. It is not specified if it is randomized or blinded.","completed","Observational Study of Photodynamic Therapy for Osseointegrated Prosthesis Infection Prevention","This observational study is looking at a new way to prevent infections around osseointegrated prostheses (a type of artificial limb that connects directly to the bone). It will involve 10 patients aged 18 or older who have an osseointegrated prosthesis and do not have an active infection or are pregnant. The study will test if using 5-aminolevulinic acid (5-ALA) cream along with a light device (photodynamic therapy or PDT) can help prevent infections. This treatment will be part of your regular care for the stoma (the opening where the prosthesis connects). The main goal is to see if this treatment is practical to use, and this will be checked after 2 weeks. The study is currently unclear on its recruitment status.","The feasibility of the treatment will be measured at 2 weeks.",121,"You would apply topical 5-ALA cream and use a light delivery device as part of your daily stoma management. The first treatment will be at the clinic, and all others will be done at home.","Not stated in the trial record.",[29],"v2"]