Obliterating Diabetic Microangiopathy of the Diabetic Foot
Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedNovember 20, 2015
March 1, 2012
8 months
March 30, 2012
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
Eligibility Criteria
30 diabetic patients with only neuropathy, 30 diabetic patients with critical limb ischemia
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetic Foot Center - IRCCS Multimedica,
Sesto San Giovanni, (Milan), Italy, 20099, Italy
Related Publications (1)
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.
PMID: 27121168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ezio Faglia, MD
IRCCS Multimedica
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
November 20, 2015
Study Start
March 1, 2012
Primary Completion
November 1, 2012
Study Completion
October 1, 2013
Last Updated
November 20, 2015
Record last verified: 2012-03