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Obliterating Diabetic Microangiopathy of the Diabetic Foot

Sponsor
IRCCS Multimedica (Other)
Overall Status
Completed
CT.gov ID
NCT02610036
Collaborator
(none)
60
Enrollment
1
Location
19
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
    Study Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2012
    Actual Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    neuropathic type 2 diabetic patients

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy Italy 20099

    Sponsors and Collaborators

    • IRCCS Multimedica

    Investigators

    • Principal Investigator: Ezio Faglia, MD, IRCCS Multimedica

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IRCCS Multimedica
    ClinicalTrials.gov Identifier:
    NCT02610036
    Other Study ID Numbers:
    • PROT 18 /2011Cardiovascular
    First Posted:
    Nov 20, 2015
    Last Update Posted:
    Nov 20, 2015
    Last Verified:
    Mar 1, 2012
    Keywords provided by IRCCS Multimedica
    diabetes
    foot ulcer
    Additional relevant MeSH terms:
    Diabetic Foot

    Study Results

    No Results Posted as of Nov 20, 2015