An observational study in Diabetic Foot Ulcers (DFU), Nutrition Assessment and Malnutrition (Calorie), sponsored by Hvidovre University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hvidovre University Hospital · 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.
The 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.
DFUs 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.
Despite 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.
Participants 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.
Eligible 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.
Background Diabetic Foot Ulcers (DFUs) affect up to one third of individuals with diabetes and are associated with systemic inflammation, impaired circulation, and metabolic disturbances that may increase nutritional requirements and may impair collagen synthesis, immune function, and tissue repair in the foot ulcer. Despite nutrition being recognized as a modifiable factor in the ulcer healing process, the nutritional status of individuals with DFUs remains insufficiently characterized, and evidence regarding clinically relevant nutritional deficiencies in this population is limited. This feasibility and pilot study is designed to test the data collection procedure and generate preliminary descriptive data on nutritional status in a Danish outpatient population, in preparation for a future full-scale multicentre study.
Study Setting and Design Prospective observational feasibility and pilot study conducted at the Wound Outpatient Clinic, Department of Orthopaedic Surgery, Hvidovre Hospital, Denmark. Data are collected at two time points: a scheduled outpatient visit (Baseline) and a telephone interview within one week.
Recruitment Eligible patients are identified through the scheduled appointment list on designated inclusion days (Monday and Wednesdays). Wound care nurses review referrals in the electronic health record system prior to each clinic day and identify potentially eligible patients in collaboration with the research team. Upon arrival, patients are informed about the opportunity to participate in a research study and if patients express interest the researcher will provide oral and written information. Written informed consent is obtained prior to any data collection.
Data collected during the outpatient visit - Baseline:
Data collected during telephone follow-up (Within One Week)
Data management All data are recorded in REDCap, supported by the Centre for IT, Medico and Telematic Services (CIMT), Capital Region of Denmark, in accordance with approval from the Danish Data Protection Agency.
Statistical analysis Feasibility outcomes will be reported as proportions with 95% confidence intervals, evaluated against an a priori success threshold of ≥70% protocol completion. Continuous variables will be summarised as means ± Standard Deviation (SD) or medians with Interquartile Range (IQR). Nutritional status will be classified according to the GLIM criteria. Associations between nutritional variables are exploratory and hypothesis-generating.
Sample Size A formal sample size calculation is not applicable. A sample of 30 participants is sufficient to assess recruitment feasibility and generate preliminary descriptive data, consistent with recommendations for pilot studies
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 191 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with non-healing diabetic foot ulcers (DFUs) receiving treatment at the outpatient clinic at Hvidovre Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion criteria for bioelectrical impedance analysis (BIA)
- Presence of a cardiac pacemaker or other implanted electronic device
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The cohort receive treatment at the Wound Outpatient Clinic, Hvidovre Hospital. No intervention is administered as part of this study.
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.
Feasibility of the data collection protocol
The primary outcome is the proportion of enrolled participants who complete all components of the data collection protocol, defined as: (1) completion of all anthropometric and functional assessments during the outpatient clinic visit, and (2) completion of the telephone interview within one week of the clinic visit. Both components must be completed for a participant to be counted as a completer. Results reported as a single proportion (%). A priori success threshold: ≥70% of enrolled participants complete all data collection components. If 40-69 % complete the data collection modifications are needed and if less that 40 % completion the study is not feasible in its current form. Unit of Measure: Percentage of eligible patients (%)
Time frame: From inclusion to completion of telephone interview, approximately 1 week
Recruitment rate
Proportion of eligible patients who consent to participate, calculated as the number of enrolled participants divided by the number of eligible patients identified during the inclusion period. Reasons for non-participation will be recorded and used descriptively to contextualize the recruitment rate. Results reported as a single percentage (%). Feasibility thresholds: * Feasible as is: ≥60% of eligible patients consent to participate * Feasible with modifications: 40-59% consent - barriers identified and addressable * Not feasible: \<40% consent - eligibility criteria or recruitment procedure require revision Unit of Measure: Percentage of eligible patients (%)
Time frame: Duration of inclusion period, approximately 3 months
Completeness of individual variables
Proportion of missing data assessed per variable across all enrolled participants. Additional variables from InBody S10 including skeletal muscle mass (kg) and ECW/TBW ratio will be assessed descriptively to evaluate data completeness and measurement feasibility for inclusion in the future full-scale study. Feasibility thresholds: * Feasible as is: ≥80% data completeness per variable * Feasible with modifications: 60-79% completeness - protocol or instrument adjustment indicated * Not feasible: \<60% completeness - variable should be reconsidered for the future full-scale study Unit of Measure: Proportion of complete data per variable (%)
Time frame: From inclusion to completion of telephone interview, approximately one week
Duration of clinic visit assessments
Time required to complete all clinic visit assessments (anthropometry, bioelectrical impedance analysis (BIA) / mid-upper arm muscle circumference (MAMC), handgrip strength, 24-hour dietary recall interview, recorded in minutes. Results reported as mean ± SD. Feasibility thresholds: * Feasible as is: Clinic visit assessments completable within 80 minutes; ≥75% of participants complete the telephone interview within 1 week * Feasible with modifications: 81-120 minutes OR 60-74% telephone completion - procedural adjustments indicated * Not feasible: \>120 minutes OR \<60% telephone completion - protocol requires substantial redesign Unit of Measure: Minutes
Time frame: Measured at baseline clinical visit and telephone interview within one week
Telephone interview completion rate
Proportion of enrolled participants who complete the telephone interview within one week of the clinic visit. Results reported as percentage (%). Feasibility thresholds: * Feasible as is: ≥75% * Feasible with modifications: 60-74% - procedural adjustments indicated * Not feasible: \<60% - protocol requires substantial redesign Unit of Measure: Percentage of participants (%)
Time frame: Measured at baseline and telephone interview within one week
Participant acceptance and compliance
Participant acceptance of and compliance with data collection procedures assessed descriptively, including proportion of participants who complete each assessment without refusal or withdrawal. Results reported as number and proportion (n, %) per assessment. Unit of Measure: Number and proportion of participants (n, %)
Time frame: Measured at baseline clinic visit
Prevalence of malnutrition risk
Proportion of participants meeting Global Leadership Initiative on Malnutrition (GLIM) criteria for malnutrition, requiring at least one phenotypic criterion (low muscle mass by bioelectrical impedance analysis (BIA) / mid-upper arm muscle circumference (MAMC), low BMI, or unintentional weight loss) and one etiologic criterion (reduced food intake assessed by 24-hour dietary recall interview and Nutritional Impact Symptoms (NIS)). Results reported as a single proportion (%). Unit of Measure: Proportion of participants meeting GLIM criteria (n, %)
Time frame: Measured at baseline clinic visit
Fat-free mass index
Fat-free mass index (kg/m²) and fat mass percentage assessed by BIA. Results reported as mean ± standard deviation (SD) and compared to age- and sex-adjusted reference values. Unit of Measure: kg/m²
Time frame: Measured at baseline clinic visit
Fat mass percentage
Fat mass percentage assessed by bioelectrical impedance analysis (BIA). Results reported as mean ± SD and compared to age- and sex-adjusted reference values. Unit of Measure: Percentage (%)
Time frame: Measured at baseline clinic visit
Mean daily energy intake
Mean daily energy intake assessed by 24-hour dietary recall. Adequacy evaluated against Nordic Nutrition Recommendations 2023. Results reported as mean ± SD. Data will be used to describe nutritional status in this patient population and to inform the design of the future full-scale study. Selected micronutrient intakes (vitamin C, vitamin D, zinc) will additionally be assessed and reported descriptively as part of the overall dietary analysis. Unit of Measure: kcal/day
Time frame: Measured at baseline clinic visit
Wound-related quality of life
Wound-related quality of life assessed by the validated Wound-QoL questionnaire, scored according to the Wound-QoL scoring manual (global score 0-4). Results reported as mean ± SD across global score and three subscales (physical, psychological, everyday life). Higher scores indicate greater impairment.
Time frame: Measured at telephone interview, within one week of clinic visit
Mean daily protein intake
Mean daily protein intake assessed by 24-hour dietary recall. Adequacy evaluated against Nordic Nutrition Recommendations 2023. Results reported as mean ± SD. Data will be used to describe nutritional status in this patient population and to inform the design of the future full-scale study. Unit of Measure: g/kg body weight/day
Time frame: Measured at baseline clinic visit
Muscle strength
Handgrip strength (kg) assessed by dynamometer (highest of three attempts, dominant hand). Results reported as mean ± SD and compared to age- and sex-adjusted normative reference values.
Time frame: Measured at baseline clinic visit
Mobility and physical activity
Physical activity and mobility will be assessed by the Life-Space Assessment (LSA-DK) questionnaire (score 0-120). Results reported as mean ± SD and distribution across mobility categories per standard LSA-DK scoring bands.
Time frame: Measured at telephone interview, within one week of clinic visit
Staff-reported feasibility
Description: Staff-reported feasibility assessed by qualitative interviews conducted after the inclusion period. Findings reported as a thematic summary of perceived barriers and facilitators. Unit of Measure: Thematic summary (qualitative)
Time frame: Following completion of inclusion period, approximately 3 months
No study locations are listed for this record.
Plan to share: Undecided — Anonymised study data may be shared with Danish researchers working within the same field, subject to the establishment of a formal data sharing agreement in accordance with the Danish Act on Processing of Personal Data (Databeskyttelsesloven) and the General Data Protection Regulation (GDPR). Data sharing will not be initiated prior to the completion of such an agreement.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 65 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 94. This study's planned 3 months is below that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 15 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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