Microangiopathy in Diabetes

NCT07145567 | Recruiting DMC

• 1 other identifier: 2023-02232-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.

Conditions

Microangiopathy; Microvascular Complications

Keywords

Laser speckle contrast imaging; Spatial frequency domain imaging; Laser doppler flowmetry; Iontophoresis; Local thermal hyperemia; Post occlusive reactive hyperemia

Outcome Measures

Primary Outcomes (1)

• Peak perfusion in response to local thermal hyperemia

  As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.

  Investigation will take within 1 day from enrollment.

Secondary Outcomes (1)

• Perfusion heterogeneity in sole of feet

  Investigation will take place within 1 day from enrollment.

Study Arms (4)

Severe diabetic microangiopathy

Severe micro-angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. Aged 18-60 years old.

Moderate diabetic microangiopathy

Moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure defined as estimated glomerular filtration rate \<60 mL/min/1.73 m2 body surface, and manifest neuropathy. Aged 18-45 years old.

Mild diabetic microangiopathy

Mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy. Aged 18-45 years old.

No diabetic microangiopathy

No microangiopathic complications, except for simplex or background retinopathy, which is an early and reversible state. Aged 18-45 years old.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient at Danderyd Hospital Diabetes Clinic

You may qualify if:

• Diabetes mellitus type 1.

You may not qualify if:

• Patients unable to understand patient information due to cognitive impairment.
• Patients unable to understand patient information due to language barriers.
• Ongoing acute infection disease or inflammatory condition.
• Pregnant or breast-feeding women.
• Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Neko Health AB: collaborator

Study Sites (1)

Danderyd University Hospital

Danderyd, Stockholm County, 182 88, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Central Study Contacts

Sara Tehrani, Medical Doctor

CONTACT

+46 08 123 550 00; sara.tehrani@ki.se

Jacob Widaeus, Medical Doctor

CONTACT

+46 08 123 596 01; jacob.widaeus@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Medical doctor, Specialist in internal medicine

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)