Immune Cells in Diabetic Chronic Foot Ulcers

NCT06154915 | Recruiting

• 1 other identifier: 2022-01416
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot; Immune Defect

Outcome Measures

Primary Outcomes (2)

• 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.

  4 years

• 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.

  4 years

Study Arms (2)

Healing Ulcer

The patients will be recruited from the doctors and the nurses of the foot clinic of Department of Endocrinology. A complete medical history and physical parameters will be collected, moreover a peripheral circulation status will assess at the time of the enrolment. During the first visit blood samples and a biopsy from the site of foot ulcers will be taken together with a picture of the ulcer. All patients will follow the medical treatments, as recommended by the multidisciplinary clinical team (for example revascularization or ulcer debriding). Intervals between visits will range between 4 to 8 weeks according to the usual medical routine. During visits 1, 2 and 3 the ulcers status will be documented by pictures, physical parameter collected, biopsies, ulcer fluid and blood samples will be taken for further analysis. At visit 3 the ulcers will be classified as "healing" if completely resolved or dramatically reduced (more than 50%), otherwise will be classified as "non-healing".

Other: medical treatments

Non-Healing Ulcer

The patients will be recruited from the doctors and the nurses of the foot clinic of Department of Endocrinology. A complete medical history and physical parameters will be collected, moreover a peripheral circulation status will assess at the time of the enrolment. During the first visit blood samples and a biopsy from the site of foot ulcers will be taken together with a picture of the ulcer. All patients will follow the medical treatments, as recommended by the multidisciplinary clinical team (for example revascularization or ulcer debriding). Intervals between visits will range between 4 to 8 weeks according to the usual medical routine. During visits 1, 2 and 3 the ulcers status will be documented by pictures, physical parameter collected, biopsies, ulcer fluid and blood samples will be taken for further analysis. At visit 3 the ulcers will be classified as "non-healing" if not resolved or not dramatically reduced (more than 50%).

Other: medical treatments

Interventions

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

Healing Ulcer; Non-Healing Ulcer

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic patients with one or more foot ulcer.

You may qualify if:

• diabetes with diabetic foot ulcer

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Huddinge, Stockholm County, 141 57, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and foot ulcer biopsies

MeSH Terms

Conditions

Diabetic Foot

Interventions

Undertreatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Services Misuse; Health Services; Health Care Facilities Workforce and Services; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• cecilia Morgantini, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Steninger

CONTACT

70 00213 45; eva.steninger@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 4, 2023
• Study Start: September 9, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

SE (1)