Diabetic Foot Clinical Trial
Official title:
Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
The purpose of this study will be the assessment of microangiopathy determined by the increase of capillary basement membrane thickness and decrease of capillary lumen area in the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients
Primary endpoint of the study is to quantitatively evaluate the presence of microangiopathy
as increase of capillary basement membrane thickness and decrease of capillary lumen area
determined by transmission electron microscopy analysis in type 2 diabetic patients with
only motor-sensory neuropathy or chronic critical ischemia affected by foot ulcer.
The following parameters will be evaluated:
- presence of capillary (n/mm2) and thrombosis (%) and correlation of this quantitative
histological data with ischemic parameters (TcPO2, ankle-brachial index) and risk of
diastasis
- correlation between presence of inflammatory infiltrate (leukocytes/mm2) with blood
inflammatory parameters (erythrocyte sedimentation rate (ESR), C-reactive protein,
alpha-2 globulin)
- rate of diastasis and/or time required for recovery associated with histopathological
data
- presence of acanthosis related to clinical and demographic variables
;
Observational Model: Case Control, Time Perspective: Prospective
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