Nutritional Status in Adults With Diabetic Foot Ulcers

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:

* Anthropometry: (height, weight, BMI). If the participant is unable to stand upright, height is estimated from knee-to-heel length or fingertip-to-sternum distance (estimated 5 minutes) * Body composition: bioelectrical impedance analysis (BIA) using the InBody S10, measuring muscle mass, fat percentage, and fluid balance. Performed between wound dressing removal and re-application. Omitted in participants with implanted electronic devices; mid-upper arm muscle circumference (MAMC) used as surrogate where BIA is not feasible (estimated 10 minutes) * Muscle strength: Handgrip dynamometry, three maximal attempts with dominant hand, highest value recorded (estimated 10 minutes) * Dietary intake: 24-hour dietary recall interview assessing all foods and beverages consumed in the preceding 24 hours. Portion sizes estimated using standardised photographic aids (Technical University of Denmark (DTU): National Dietary Survey) (estimated duration: 40 minutes). Macro- and micronutrient intake are calculated using www.Vitakost.dk

Data collected during telephone follow-up (Within One Week)

* Malnutrition is diagnosed according to the Global Leadership Initiative on Malnutrition (GLIM), requiring at least one phenotypic criterion (low muscle mass by BIA or MAMC, low BMI, or unintentional weight loss) and one etiologic criterion. In this pilot study, the etiologic criterion will be based solely on reduced food intake or assimilation, assessed by 24-hour dietary recall and the presence of nutritional impact symptoms (NIS). Inflammatory markers are not available as routine clinical data in this outpatient setting and will not be included in GLIM classification. The availability and accessibility of routine biochemical data will be assessed as part of the feasibility evaluation to inform data collection procedures for the future full-scale study. * NIS factors: The Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF, Box 3) will be used to identify symptoms impairing food intake, including nausea, vomiting, diarrhoea, constipation, mouth sores, dry mouth, pain, taste changes, and reduced appetite. NIS data will contribute to the etiologic criterion of reduced food intake or assimilation within the GLIM malnutrition assessment * Physical activity and mobility: (Life-Space Assessment- Denmark, LSA-DK) assessing mobility range inside and outside the home over the preceding four weeks * Wound-related quality of life: Wound-QoL questionnaire, covering physical, psychological, and everyday life domains. Scored according to the Wound-QoL scoring manual; higher scores indicate greater impairment * Demographic data: age, sex, ethnic background, marital status, living situation, educational level, work status, and need for community care or nursing. * Clinical data include comorbidity burden assessed using the Charlson Comorbidity Index, diabetes type and duration, latest glycated haemoglobin (HbA1c) value, smoking status, foot deformities, previous foot ulceration, number of active ulcers, previous ulcer healing and recurrence, antibiotic treatment related to the foot ulcer, and symptoms of infections (fever).

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

• Recruitment rate [Time frame: Duration of inclusion period, approximately 3 months]
• Completeness of individual variables [Time frame: From inclusion to completion of telephone interview, approximately one week]
• Duration of clinic visit assessments [Time frame: Measured at baseline clinical visit and telephone interview within one week]
• Telephone interview completion rate [Time frame: Measured at baseline and telephone interview within one week]
• Participant acceptance and compliance [Time frame: Measured at baseline clinic visit]
• Prevalence of malnutrition risk [Time frame: Measured at baseline clinic visit]
• Fat-free mass index [Time frame: Measured at baseline clinic visit]
• Fat mass percentage [Time frame: Measured at baseline clinic visit]
• Mean daily energy intake [Time frame: Measured at baseline clinic visit]
• Wound-related quality of life [Time frame: Measured at telephone interview, within one week of clinic visit]
• Mean daily protein intake [Time frame: Measured at baseline clinic visit]