Understanding immune cells in diabetic foot ulcers
Official title: Characterise the Immunological Response of Diabetic Patients With Chronic Foot Ulcers
Run by Karolinska Institutet · NCT06154915 · Data updated 2026-11-12
This study looks at how immune cells behave in people with diabetes who have foot ulcers to see if understanding them can help improve healing for those with chronic wounds.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 98 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Status | Recruiting |
| Started | September 9, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06154915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with diabetes who have a diabetic foot ulcer.
✕Probably not a fit
Patients with impaired cognitive function, ongoing immune suppressive treatment, active cancer, or chronic inflammatory diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the role of immune cells in patients with diabetes who have chronic foot ulcers. Researchers will compare blood and tissue samples from diabetic patients with healing or healed ulcers to those with non-healing, chronic ulcers. The study focuses on characterizing the immunological response and identifying potential therapeutic targets for chronic wound treatment. By utilizing advanced methodologies such as transcriptomic and proteomic analysis at the single-cell level, the study seeks to uncover the mechanisms behind impaired healing in diabetic foot ulcers.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for improving healing in diabetic foot ulcers.
How similar studies have gone: Other studies have shown promise in understanding immune responses in wound healing, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diabetes with diabetic foot ulcer Exclusion Criteria: * impaired cognitive function * on-going immune suppressive treatment * diagnosed active cancer * cancer treatment * known chronic inflammatory disease
Where it's running
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Karolinska University Hospital
Huddinge, Stockholm County, Sweden Recruiting
Study contacts
- Principal investigator: cecilia Morgantini, MD — Karolinska Institutet
- Study coordinator: Eva Steninger
- Email: eva.steninger@regionstockholm.se
- Phone: 70 00213 45
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Miro3D Wound Matrix for Diabetic Foot Ulcers
This study tests whether adding Miro3D Wound Matrix to standard care helps healing diabetic foot ulcers in adults.
-
Topical Capsadyn (palmitated capsaicin) for diabetic neuropathic foot pain
This study will test whether a topical Capsadyn cream can reduce foot pain in adults with diabetic peripheral neuropathy.
-
Single-layer placental graft plus standard care for stubborn diabetic foot ulcers
This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.
-
Using human placental membrane wraps with regular wound care to help heal stubborn diabetic foot and venous leg ulcers
This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.