跳至主要内容
临床试验/NCT06154915
NCT06154915
招募中
不适用

Characterise the Immunological Response of Diabetic Patients With Chronic Foot Ulcers

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 40 人2022年9月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Diabetic Foot
发起方
Karolinska Institutet
入组人数
40
试验地点
1
主要终点
Characterize the longitudinal signature of circulating monocytes in the healing process of diabetic patients
状态
招募中
最后更新
8个月前

概览

简要总结

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).

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2022年9月9日
结束日期
2029年12月31日
最后更新
8个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Cecilia Morgantini

MD, PhD

Karolinska Institutet

入排标准

入选标准

  • diabetes with diabetic foot ulcer

排除标准

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

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

研究点 (1)

Loading locations...

相似试验