Clinical trial NCT02610036: Obliterating Diabetic Microangiopathy of the Diabetic Foot
Official title: Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Keywords: diabetes
foot ulcer
Lead sponsor: IRCCS Multimedica
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 diabetic patients with only neuropathy, 30 diabetic patients with critical limb ischemia

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

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

Eligibility 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

Primary outcomes:
measure: presence of microangiopathy
timeFrame: 24 hours after surgical amputation at the first ray level for treatment of foot ulcer
Secondary outcomes:
Other outcomes:
Locations:
city: Sesto San Giovanni
country: Italy
facility: Diabetic Foot Center - IRCCS Multimedica,
state: (Milan), Italy
Study officials:
affiliation: IRCCS Multimedica
name: Ezio Faglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.