Nutritional Status in Adults With Diabetic Foot Ulcers

Summary

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.

Conditions

• Diabetic Foot Ulcers (DFU)
• Nutrition Assessment
• Malnutrition (Calorie)
• Ulcer Foot
• Dietary Intake Assessment
• Bio-Impedance Measurements
• Wound Healing

Interventions

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.

Sponsors & Collaborators

• The Novo Nordic Foundation

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Hvidovre University Hospital

  lead OTHER

Principal Investigators

• Pia S Jensen, PhD · Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-02

Primary Completion

2026-09-30

Completion

2026-10-30