Immune Cells in Diabetic Chronic Foot Ulcers

Condition(s) studied

Investigational drug(s) / intervention(s)

medical treatments: 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

Study 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).

Eligibility

Primary outcome measure(s)

• Characterize the longitudinal signature of circulating monocytes in the healing process of diabetic patients — 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.
• Determine the functional contribution of macrophages to diabetic chronic foot ulcers — 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.

Trial sites (1)

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