Obliterating Diabetic Microangiopathy of the Diabetic Foot

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer

Conditions
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Diabetic Foot

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- adult type 2 diabetic patients of either gender diabetes for more than 10 years motor-sensory diabetic neuropathy with or without chronic critical ischemia local residents ulcer with surgical therapy indication of removal the 1st ray because of gangrene or osteomyelitis Exclusion Criteria: type 1 diabetic patients diabetes for less than 10 years renal replacement therapy urgent surgical procedure for sepsis immunosuppressive therapy not local residents Cancer with adverse prognosis in months, or chemotheraputic treatment Ongoing or planned pregnancy Lack of consent to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neuropathic type 2 diabetic patients<br>the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients | |
| neuroischemic type 2 diabetic patients<br>the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of microangiopathy | presence of microangiopathy as increase of capillary basement membrane thickness and decrease of capillary lumen area by transmission electron microscopy in the skin of type 2 diabetic patients with foot ulcer | 24 hours after surgical amputation at the first ray level for treatment of foot ulcer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, foot ulcer