Obliterating Diabetic Microangiopathy of the Diabetic Foot

IRCCS Multimedica

Status: Completed

Conditions: Diabetic Foot

Study type: Observational

Funder types: Other

Identifiers

NCT02610036

PROT 18 /2011Cardiovascular

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

neuropathic type 2 diabetic patients

Description:

the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients

neuroischemic type 2 diabetic patients

Description:

the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients