Obliterating Diabetic Microangiopathy of the Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610036
• Other study ID #: PROT 18 /2011Cardiovascular
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: November 19, 2015
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2012
• Source: IRCCS Multimedica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Foot

Locations

Country	Name	City	State
Italy	Diabetic Foot Center - IRCCS Multimedica,	Sesto San Giovanni	(Milan), Italy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Multimedica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of microangiopathy	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	24 hours after surgical amputation at the first ray level for treatment of foot ulcer	No