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Nutritional Status in Adults With Diabetic Foot Ulcers

Study acronym: NutriDFU-P
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 30, 2026
See other at-risk trials from Hvidovre University Hospital

Record History

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  1. Notable Start date: Jun 2, 2026 to Sep 21, 2026 Show 6 more changesShow less
    • Primary completion pushed from Sep 30, 2026 to Dec 30, 2026
    • Study completion pushed from Oct 30, 2026 to Mar 1, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Study description expanded, about 10 words
    • Publications: details revised at 9 of 9 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07621770
Lead Sponsor Hvidovre University Hospital
Collaborators: The Novo Nordic Foundation, Copenhagen University Hospital, Hvidovre
Conditions
(from sponsor)
Diabetic Foot Ulcers (DFU), Nutrition Assessment, Malnutrition (Calorie), Ulcer Foot, Dietary Intake Assessment, Bio-Impedance Measurements, Wound Healing
Related terms Diabetic Foot, Foot Ulcer, Malnutrition
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov