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.
Age ≥ 18 years
Diagnosed with diabetes type 1 or type 2
Presence of one or more DFUs
Receiving treatment in a participating outpatient wound clinic
Above ankle amputation of the contralateral leg
Current treatment with intravenous antibiotics for acute infection.
Current hospitalisation for acute surgical management of the foot ulcer
Declining or unable to participate in a telephone follow-up interview.
Adult patients with non-healing diabetic foot ulcers (DFUs) receiving treatment at the outpatient clinic at Hvidovre Hospital.
Cohort
Prospective
Protein supplementation and nutrition education
BehavioralThe 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 (%)
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 (%)
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 (%)
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
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 (%)
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.
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.
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)
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Hvidovre University Hospital
Lead sponsor
The Novo Nordic Foundation
Collaborator
Copenhagen University Hospital, Hvidovre
Collaborator
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