Nutritional Status in Adults With Diabetic Foot Ulcers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHvidovre University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Protein supplementation and nutrition education

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Hvidovre University Hospital

Lead sponsor

The Novo Nordic Foundation

Collaborator

Copenhagen University Hospital, Hvidovre

Collaborator