NCT02610036

Obliterating Diabetic Microangiopathy of the Diabetic Foot

Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: IRCCS Multimedica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Diabetic Foot

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-11-01
• Completion: 2013-10-01
• First posted: 2015-11-20
• Last updated: 2015-11-20

Locations

1 site across 1 country: Italy