Nutritional Status in Adults With Diabetic Foot Ulcers

N/ANot Yet RecruitingNCT07621770

Hvidovre University Hospital30 enrolled

Overview

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: * 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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, %)