Immune Cells in Diabetic Chronic Foot Ulcers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-98
SponsorKarolinska Institutet
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
diabetes with diabetic foot ulcer
Disqualifiers
impaired cognitive function
on-going immune suppressive treatment
diagnosed active cancer
cancer treatment
Trial population
Diabetic patients with one or more foot ulcer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
medical treatments
Other interventionAll 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Healing Ulcer1 intervention
Group B: Non-Healing Ulcer1 intervention
Trial outcomes
Primary outcomes
1
Characterize the longitudinal signature of circulating monocytes in the healing process of diabetic patients
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.
Time frame
4 years2
Determine the functional contribution of macrophages to diabetic chronic foot ulcers
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.
Time frame
4 yearsSponsors and contacts
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Source ClinicalTrials.gov