Immune Cells in Diabetic Chronic Foot Ulcers

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06154915
Study type	Observational
Source	Karolinska Institutet
Contact	Eva Steninger
Phone	70 00213 45
Email	eva.steninger@regionstockholm.se
Status	Recruiting
Phase
Start date	September 9, 2022
Completion date	December 31, 2029

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Completed	`NCT02373592` - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer	N/A
Active, not recruiting	`NCT01903044` - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating	Phase 1/Phase 2
Completed	`NCT02092870` - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds	Phase 2
Completed	`NCT01212120` - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections	N/A
Completed	`NCT00402727` - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection	Phase 3
Recruiting	`NCT04085705` - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Completed	`NCT04480801` - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer	N/A
Not yet recruiting	`NCT04537676` - Patient Empowerment Study
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A
Recruiting	`NCT05974592` - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program	N/A
Not yet recruiting	`NCT04630795` - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting	`NCT05431660` - Diabetic Foot School and Biomechanics	N/A
Completed	`NCT05101473` - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study	N/A
Completed	`NCT05123157` - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation	`NCT05043636` - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed	`NCT03254095` - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.
Terminated	`NCT01657318` - Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers
Completed	`NCT06373809` - Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy	Early Phase 1