Nutritional Status in Adults With Diabetic Foot Ulcers

NCT07621770 | Not Yet Recruiting

• 4 other identifiers: HvidovreUH_p-2025-19880NNF19OC0058628p-2025-19880F-25076787
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

DFU; Malnutrition; Wound healing; Nutritional assessment; outpatient; hard-to-heal ulcer

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  From inclusion to completion of telephone interview, approximately 1 week

Secondary Outcomes (11)

• Recruitment rate

  Duration of inclusion period, approximately 3 months

• Completeness of individual variables

  From inclusion to completion of telephone interview, approximately one week

• Duration of clinic visit assessments

  Measured at baseline clinical visit and telephone interview within one week

• Telephone interview completion rate

  Measured at baseline and telephone interview within one week

• Participant acceptance and compliance

  Measured at baseline clinic visit

Other Outcomes (3)

• Muscle strength

  Measured at baseline clinic visit

• Mobility and physical activity

  Measured at telephone interview, within one week of clinic visit

• Staff-reported feasibility

  Following completion of inclusion period, approximately 3 months

Study Arms (1)

Single cohort: Adults with type 1 or type 2 diabetes and one or more active DFUs

The cohort receive treatment at the Wound Outpatient Clinic, Hvidovre Hospital. No intervention is administered as part of this study.

Behavioral: Protein supplementation and nutrition education

Interventions

Protein supplementation and nutrition education BEHAVIORAL

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.

Single cohort: Adults with type 1 or type 2 diabetes and one or more active DFUs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with non-healing diabetic foot ulcers (DFUs) receiving treatment at the outpatient clinic at Hvidovre Hospital.

You may qualify if:

• 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
• Able to provide written informed consent

You may not qualify if:

• 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.
• Current long-term enteral (tube feeding) or parenteral nutritional support.
• \- Presence of a cardiac pacemaker or other implanted electronic device

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• The Novo Nordic Foundation: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator

Related Publications (9)

• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.

  PMID: 34812790 BACKGROUND

• Knudsen JT, Johansen CW, Hansen AO, Eshoj HR. The Danish wound-quality of life (Wound-QoL) questionnaire: Translation and psychometric properties. Wound Repair Regen. 2021 Nov;29(6):973-984. doi: 10.1111/wrr.12957. Epub 2021 Jul 13.

  PMID: 34255906 BACKGROUND

• Pedersen MM, Kjaer-Sorensen P, Midtgaard J, Brown CJ, Bodilsen AC. A Danish version of the life-space assessment (LSA-DK) - translation, content validity and cultural adaptation using cognitive interviewing in older mobility limited adults. BMC Geriatr. 2019 Nov 15;19(1):312. doi: 10.1186/s12877-019-1347-0.

  PMID: 31729972 BACKGROUND

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 BACKGROUND

• Tobberup R, Jager-Wittenaar H, Sorensen J, Kopp LHP, Svarstad P, Saetre P, Ottery FD. Translation and cultural adaptation of the scored Patient-Generated Subjective Global Assessment (PG-SGA(c)). Clin Nutr ESPEN. 2022 Feb;47:215-220. doi: 10.1016/j.clnesp.2021.12.012. Epub 2021 Dec 17.

  PMID: 35063204 BACKGROUND

• Da Porto A, Miranda C, Brosolo G, Zanette G, Michelli A, Ros RD. Nutritional supplementation on wound healing in diabetic foot: What is known and what is new? World J Diabetes. 2022 Nov 15;13(11):940-948. doi: 10.4239/wjd.v13.i11.940.

  PMID: 36437863 BACKGROUND

• Moore ZE, Corcoran MA, Patton D. Nutritional interventions for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev. 2020 Jul 17;7(7):CD011378. doi: 10.1002/14651858.CD011378.pub2.

  PMID: 32677037 BACKGROUND

• Barnes JA, Eid MA, Creager MA, Goodney PP. Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease. Arterioscler Thromb Vasc Biol. 2020 Aug;40(8):1808-1817. doi: 10.1161/ATVBAHA.120.314595. Epub 2020 Jun 25.

  PMID: 32580632 BACKGROUND

• Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.

  PMID: 37395769 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

no samples are collected

MeSH Terms

Conditions

Diabetic Foot; Malnutrition; Foot Ulcer

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Nutrition Disorders; Nutritional and Metabolic Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Pia S Jensen, PhD

  Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia S Jensen, PhD

CONTACT

+45 38622464; Ann.Pia.Soee.Lytken.Jensen@regionh.dk

Julie W Egholm, MD

CONTACT

julie.weber.egholm.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD, Associate Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 2, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05