Diabetic FootNCT02610036
Obliterating Diabetic Microangiopathy of the Diabetic Foot
An observational study of Diabetic Foot, run by IRCCS Multimedica at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 diabetic patients with only neuropathy, 30 diabetic patients with critical limb ischemia
Who may be able to join
- 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
Who cannot join
- type 1 diabetic patients
- diabetes for less than 10 years
- renal replacement therapy
- urgent surgical procedure for sepsis
- immunosuppressive therapy
- not local residents
Show all 9Show fewer
- Cancer with adverse prognosis in months, or chemotheraputic treatment
- Ongoing or planned pregnancy
- Lack of consent to participate to the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Diabetic Foot Center - IRCCS Multimedica,
Sesto San Giovanni, (Milan), Italy, 20099
About this study
Official title: Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
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
Read the 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
- Conditions
- Diabetic Foot
- Keywords
- diabetes, foot ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after surgical amputation at the first ray level for treatment of foot ulcer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezio Faglia, MD, Principal investigator, IRCCS Multimedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610036
- Sponsor's protocol ID
- PROT 18 /2011Cardiovascular
- Status last verified
- Mar 2012
- First submitted
- 30 Mar 2012
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27121168
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02610036
- Acronym / sponsor ID
- PROT 18 /2011Cardiovascular
- Conditions
- Diabetic Foot
- Keywords
- diabetes, foot ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 diabetic patients with only neuropathy, 30 diabetic patients with critical limb ischemia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- type 1 diabetic patients
- diabetes for less than 10 years
- renal replacement therapy
- urgent surgical procedure for sepsis
- immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of microangiopathy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 27121168Fiordaliso 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.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezio Faglia, MD principal investigator
IRCCS Multimedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by IRCCS Multimedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of microangiopathy (time frame: 24 hours after surgical amputation at the first ray level for treatment of foot ulcer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.