[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639806":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":33,"collaborators":36,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":10},{"fullName":5,"class":6},"Hvidovre University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single cohort: Adults with type 1 or type 2 diabetes and one or more active DFUs",null,"The cohort receive treatment at the Wound Outpatient Clinic, Hvidovre Hospital. No intervention is administered as part of this study.",[13],"Behavioral: Protein supplementation and nutrition education",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"BEHAVIORAL","Protein supplementation and nutrition education","The intervention consists of nutrition education and oral protein supplementation. Participants receive an information leaflet and brief guidance on protein intake for wound healing, along with an offer of a protein drink during outpatient visits.",[9],[21],{"name":22,"affiliation":23,"role":24},"Pia S Jensen, PhD","Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+45 38622464","Ann.Pia.Soee.Lytken.Jensen@regionh.dk",{"name":31,"role":27,"phone":10,"phoneExt":10,"email":32},"Julie W Egholm, MD","julie.weber.egholm.01@regionh.dk",{"type":24,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Pia Søe Jensen","PHD, Associate Professor",[37,39],{"name":38,"class":6},"The Novo Nordic Foundation",{"name":40,"class":6},"Copenhagen University Hospital, Hvidovre","100639806","nutritional-status-in-adults-with-diabetic-foot-ulcers-100639806",false,"NCT07621770","Nutritional Status in Adults With Diabetic Foot Ulcers","Nutritional Status in Adults With Diabetic Foot in an Outpatient Wound Clinic: A Feasibility and Pilot Study","NutriDFU-P","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with diabetes type 1 or type 2\n* Presence of one or more DFUs\n* Receiving treatment in a participating outpatient wound clinic\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Above ankle amputation of the contralateral leg\n* Current treatment with intravenous antibiotics for acute infection.\n* Current hospitalisation for acute surgical management of the foot ulcer\n* Declining or unable to participate in a telephone follow-up interview.\n* Current long-term enteral (tube feeding) or parenteral nutritional support.\n\nExclusion criteria for bioelectrical impedance analysis (BIA)\n\n\\- Presence of a cardiac pacemaker or other implanted electronic device","ALL","18 Years",{"count":52,"type":53},30,"ESTIMATED","OBSERVATIONAL","This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection.\n\nThe secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study.\n\nDFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing.\n\nDespite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited.\n\nParticipants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit.\n\nEligible participants are adults (\\>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.",[57,58,59,60,61,62,63],"Diabetic Foot Ulcers (DFU)","Nutrition Assessment","Malnutrition (Calorie)","Ulcer Foot","Dietary Intake Assessment","Bio-Impedance Measurements","Wound Healing",[65,66,67,68,69,70],"DFU","Malnutrition","Wound healing","Nutritional assessment","outpatient","hard-to-heal ulcer","NOT_YET_RECRUITING","2026-05-29",{"date":74,"type":75},"2026-06-02","ACTUAL",{"date":74,"type":53},{"date":78,"type":53},"2026-10-30",{"name":5,"class":6}]