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Foot, DiabeticNCT05243368

Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics

A study testing Personalized Nutritional Intervention in people with Foot, Diabetic, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and oxidative stress increases. This is an unfavorable microenvironment for healing. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Foot, Diabetic
What is being tested?
Personalized Nutritional Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
20 Oct 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signature of the informed consent
  • Age between 50 and 80 years
  • Diagnosis of Diabetes Mellitus for more than 1 year
  • Documented diagnosis of peripheral artery disease
  • HbA1c < 9%
  • Category 5 in the Rutherford-Becker classification

Who cannot join

  • Poor cognitive function, dementia or psychiatric conditions
  • Osteomyelitis, gangrene, malignancy or immunocompromised disease
  • Thromboangiitis obliterans or Buerger's disease
  • Clinical evidence of invasive infection in the target limb requiring IV antibiotherapy
  • Presence of neuropathic ulcers only
  • Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Reina Sofía de Córdoba

    Córdoba, Andalusia, 14004

Other trials in Spain

About this study

Official title: Evaluation of Personalized Nutritional Intervention Together With the Application of MSC-derived Exosomes on the Regenerative Capacity and Wound Healing of Cutaneous Ulcers in Diabetics

The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and oxidative stress increases. This is an unfavorable microenvironment for healing. A major risk factor in the development of CCU is nutritional deficiency. Healing needs energy and nutrients for regeneration. In diabetics the malnutrition can be more than 60%. However, although the provision of certain nutrients can improve the healing capacity, it is not a common clinical practice to nutritionally evaluate diabetic with CCU. Exosomes are extracellular vesicles that reflect the physiological state of the cells producing them. Stem cell derivatives exosomes are rich in factors, that can provide a favorable microenvironment for tissue regeneration.

The aim of this project is to develop a therapeutic process to accelerate the healing of diabetic CCU, based on the correction of nutritional deficiencies, to improve the regenerative capacity, together with the application of exosomes from mesenchymal stem-cell (MSC) in the wound, creating a microenvironment that favors tissue regeneration. For this, a pilot clinical trial with diabetic patients with CCU is proposed, to evaluate the effect of personalized nutritional supplementation on healing and regenerative capacity.

Conditions
Foot, Diabetic
Being tested
Personalized Nutritional Intervention
Keywords
Dietary Supplementations, Wound Healing, Diabetes Mellitus, Malnutrition
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Nutritional InterventionDietary supplement

    Those with malnutrition criteria will also receive a nutritional supplement (e.g. fortimel cubitan, advanced or extra, Nutricia) or another of similar composition, in case of intolerance to the first option. The aim will be to provide at least 50% of the recommended intakes for the main nutrients related to wound healing.

Study groups in NCT05243368
Study groupRoleWhat they receive
Nutritional Intervention (NI)ExperimentalIn addition to the usual treatment, will receive dietary advice and a nutritional supplement, according to the results of their evaluation in the Endocrinology Service
Receives: Dietary Supplement: Personalized Nutritional Intervention
Control (C)No interventionWho will continue with their usual treatments in the Diabetic Foot Unit and they will receive dietary advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ulcer evaluation

    Change from baseline in size ulcer assessed by picture, including ruler to measure their size

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Secondary outcomes (7)

  1. Composite measure of markers of nutritional status

    Change from baseline in nutritional status assessed from blood samples

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  2. Composite measure of haemogram

    Change from baseline in haemogram assessed from blood samples

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  3. Hemoglobin A1c (HbA1c) Test for Diabetes

    Change from baseline in HbA1c (%) assessed from blood samples

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  4. Measure of markers of nutritional status, include to thyrotropin

    Change from baseline in thyrotropin (mlU/L) assessed from blood samples

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  5. Ultrasensitive C-reactive Protein (CRP) test

    Change from baseline in CRP (mg/L) assessed from blood samples

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  6. Quantification of circulating endothelial progenitor cells (EPC)

    Change from baseline in total CD34+ or CD133+ cells expressing vascular endothelial growth factor receptor 2 (VEGFR2) analyzed by flow cytometry

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

  7. Concentration of stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor A (VEGFA)

    Change from baseline in concentration of SDF-1 and VEGFA factors in serum by ELISA

    Measured: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start20 Oct 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243368
Sponsor's protocol ID
PI21/01935
Status last verified
Nov 2026
First submitted
20 Jan 2022
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19.

    PubMed 24867069

  • Basiri R, Spicer MT, Levenson CW, Ormsbee MJ, Ledermann T, Arjmandi BH. Nutritional Supplementation Concurrent with Nutrition Education Accelerates the Wound Healing Process in Patients with Diabetic Foot Ulcers. Biomedicines. 2020 Aug 3;8(8):263. doi: 10.3390/biomedicines8080263.

    PubMed 32756299

  • 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.

    PubMed 30181091

  • Haughey L, Barbul A. Nutrition and Lower Extremity Ulcers: Causality and/or Treatment. Int J Low Extrem Wounds. 2017 Dec;16(4):238-243. doi: 10.1177/1534734617737639. Epub 2017 Nov 16.

    PubMed 29145757

  • Kurian SJ, Miraj SS, Benson R, Munisamy M, Saravu K, Rodrigues GS, Rao M. Vitamin D Supplementation in Diabetic Foot Ulcers: A Current Perspective. Curr Diabetes Rev. 2021;17(4):512-521. doi: 10.2174/1573399816999201012195735.

    PubMed 33045979

  • Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.

    PubMed 23810110

  • Zhang SS, Tang ZY, Fang P, Qian HJ, Xu L, Ning G. Nutritional status deteriorates as the severity of diabetic foot ulcers increases and independently associates with prognosis. Exp Ther Med. 2013 Jan;5(1):215-222. doi: 10.3892/etm.2012.780. Epub 2012 Oct 30.

    PubMed 23251271

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Nutritional Intervention in people with Foot, Diabetic, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ulcer evaluation (time frame: Baseline, 30 days after treatment initiation, 60 days after treatment initiation and 90 days after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243368, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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