๐ฌIn plain words
What the trial is, and whether it could suit you
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Phase 1: Severe Diabetic Complications (50 patients)
Inclusion Criteria:
* Severe type 1 diabetes (microangiopathy / diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.
* Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered
Phase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included.
Inclusion criteria:
* Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)
* Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.
* Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b), 100 patients.
* Patient with moderate 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) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients.
Healthy controls:
\- Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease.
Exclusion Criteria:
* Patients unable to understand patient information due to cognitive impairment
* Patients unable to understand patient information due to language barriers
* Ongoing acute infection or inflammatory condition
* Pregnant or breastfeeding women
* Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices