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NCT Number: NCT06154915

Immune Cells in Diabetic Chronic Foot Ulcers

The goal of this observational study is to learn about the role of immune cells in patients with diabetes and chronic foot ulcers. Researchers will compare blood and tissue samples of patients with diabetes and a foot ulcer that is healing or healed compared to those diabetic patients where the foot ulcers is not healing (chronic ulcer).

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Immune Defect Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–98 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Huddinge, Stockholm County, 141 57, Sweden

Location status: Recruiting

Location contact

Cecilia Morgantini

CONTACT

[email protected]

+46709886692

About this study

Diabetic foot ulcer (DFU) requires frequent hospital visits, anti-biotic therapies, and surgical procedures. Not only this approach has debilitating consequences for patients and enormous costs for the health care system, but it is often not sufficient to prevent lower limb amputation. The immunological response in wound healing is mainly orchestrated by recruited monocytes and skin macrophages. The current hypothesis is that hyperglycaemia sustains an activated macrophages' phenotype that inhibits wound healing. However, well controlled diabetes is not associated with better healing, and not all the diabetic patients develop chronic foot ulcers. In this project, the investigators aim to characterize the immunological response of patients with DFU to discover new therapeutic targets for the treatment of chronic wounds. The investigator suggest that an altered metabolic local environment can re-program monocytes/macrophages towards dysfunctional phenotypes unable to accomplish the healing process. Here, by using a longitudinal study cohort combined with clinical information, transcriptomic and proteomic analysis at single cell level, researchers will characterize the landscape of monocytes/macrophage populations involved in healing, and non-healing, foot ulcers. Functional validation will be performed in human skin organoids. My group's unique access to patient material combined with cutting-edge methodologies provides an exceptional platform to identify genes and pathways involved in chronic DFU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes with diabetic foot ulcer

Exclusion criteria

  • impaired cognitive function
  • on-going immune suppressive treatment
  • diagnosed active cancer
  • cancer treatment
  • known chronic inflammatory disease

Treatment and study plan

medical treatments

Other

All patients will follow the medical treatments, as recommended by the multidisciplinary clinical team (for example revascularization or ulcer debriding) according to the best standard of care

Primary outcomes

  1. Characterize the longitudinal signature of circulating monocytes in the healing process of diabetic patients

    Time frame: 4 years

    An aliquot of peripheral blood mononuclear cells obtained from patients at the first visit will be used to perform single-cell RNA-sequencing. Transcriptomic results of patients with healing ulcers will be compared with those with non-healing ulcers in order to identify different circulating monocytes populations only present in non-healing diabetic patients.

  2. Determine the functional contribution of macrophages to diabetic chronic foot ulcers

    Time frame: 4 years

    A freshly taken punch biopsy take from patient at visit 1 will be dissociated to a cell suspension. Single cell RNA sequencing analysis will be performed on these cells in order to study different cell populations. Bioinformatic analysis of sequenced data will identify macrophage's population, map cell heterogeneity and identify specific cell signature of healing compared to non-healing ulcers.

    Moreover, by comparing the transcriptomic signature of the cell populations in the tissue with circulating monocytes population defined in aim 1, researchers will verify whether specific populations are already present in circulation or appearing once the cells are in the tissue, or derived skin-resident macrophages.

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Steninger

CONTACT

[email protected]

70 00213 45 ext. 0046

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Characterise the Immunological Response of Diabetic Patients With Chronic Foot Ulcers

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Dec 4, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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