Clinical trial NCT06154915: Immune Cells in Diabetic Chronic Foot Ulcers
Official title: Characterise the Immunological Response of Diabetic Patients With Chronic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot
Immune Defect
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients with one or more foot ulcer.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterize the longitudinal signature of circulating monocytes in the healing process of diabetic patients
timeFrame: 4 years
measure: Determine the functional contribution of macrophages to diabetic chronic foot ulcers
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: cecilia Morgantini, MD
role: PRINCIPAL_INVESTIGATOR
References: