Obliterating Diabetic Microangiopathy of the Diabetic Foot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Diabetic Foot

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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neuropathic type 2 diabetic patients

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

No interventions assigned to this group

neuroischemic type 2 diabetic patients

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ezio Faglia, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Multimedica

Locations

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Diabetic Foot Center - IRCCS Multimedica,

Sesto San Giovanni, (Milan), Italy, Italy

Site Status

Countries

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Italy

References

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Fiordaliso F, Clerici G, Maggioni S, Caminiti M, Bisighini C, Novelli D, Minnella D, Corbelli A, Morisi R, De Iaco A, Faglia E. Prospective study on microangiopathy in type 2 diabetic foot ulcer. Diabetologia. 2016 Jul;59(7):1542-1548. doi: 10.1007/s00125-016-3961-0. Epub 2016 Apr 28.

Reference Type DERIVED

PMID: 27121168 (View on PubMed)

Other Identifiers

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PROT 18 /2011Cardiovascular

Identifier Type: -

Identifier Source: org_study_id