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Completed

NCT Number: NCT02610036

Obliterating Diabetic Microangiopathy of the Diabetic Foot

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. presence of microangiopathy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Multimedica

Other

Registry information

Official study title

Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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