Obliterating Diabetic Microangiopathy of the Diabetic Foot

Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02610036

Enrollment

Registered

2015-11-20

Start date

2012-03-31

Completion date

2013-10-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

diabetes, foot ulcer

Brief 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
presence of microangiopathy	24 hours after surgical amputation at the first ray level for treatment of foot ulcer	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

Countries

Italy

Outcome results