Diabetes and Risk of Diabetic Foot UlcerPIV & MPPNCT03213093
Pressure and Diabetic Foot
A study testing Measure of cutaneous microcirculation in people with Diabetes and Risk of Diabetic Foot Ulcer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes and Risk of Diabetic Foot Ulcer
- What is being tested?
- Measure of cutaneous microcirculation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years
- Type 2 diabetic subject
- Absence of active diabetic foot ulcer
- Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
- absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
- alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"
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- alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"
- History of diabetic foot ulcer for the "grade 3"
- Signature of consent to participate in the study
Who cannot join
- Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
- Pregnancy
- Congenital methemoglobinemia.
- Porphyria
- Skin injured on the tibia, whatever the lesion
- Recent major cardiovascular history (less than 3 months)
- Severe renal disease (serum creatinine> 300 μmol.l-1)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
service d'endocrinologie, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Julien VOUILLARMET, MD, julien.vouillarmet@chu-lyon.fr
About this study
Official title: Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.
- Conditions
- Diabetes and Risk of Diabetic Foot Ulcer
- Being tested
- Measure of cutaneous microcirculation
- Keywords
- Diabetes, Diabetic Foot Ulcer, Plantar pressure
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of cutaneous microcirculationOther
Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with a risk of diabetic foot ulcer | Other | Not described Receives: Other: Measure of cutaneous microcirculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of incidence of diabetic foot ulcer
A diabetic foot ulcer is defined as a breakdown in the skin under malleolus
Measured: At any time during a 3 years follow-up
Secondary outcomes (1)
Neurovascular response to pressure
Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit.
Measured: At the end of the 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Dec 2017
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes and Risk of Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213093
- Sponsor's protocol ID
- 69HCL16_0168
- Acronym
- PIV & MPP
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2017
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03213093
- Acronym / sponsor ID
- PIV & MPP / 69HCL16_0168
- Conditions
- Diabetes and Risk of Diabetic Foot Ulcer
- Keywords
- Diabetes, Diabetic Foot Ulcer, Plantar pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with a risk of diabetic foot ulcer | Other | Other: Measure of cutaneous microcirculation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years
- Type 2 diabetic subject
- Absence of active diabetic foot ulcer
- Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
- absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
Key exclusion criteria (7 listed)
- Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
- Pregnancy
- Congenital methemoglobinemia.
- Porphyria
- Skin injured on the tibia, whatever the lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of cutaneous microcirculationMeasure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine | Other | Diabetic patients with a risk of diabetic foot ulcer |
Primary outcome
the rate of incidence of diabetic foot ulcer
Time frame: At any time during a 3 years follow-up
A diabetic foot ulcer is defined as a breakdown in the skin under malleolus
1 secondary outcome
Neurovascular response to pressure
Time frame: At the end of the 3-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of cutaneous microcirculation in people with Diabetes and Risk of Diabetic Foot Ulcer, run by Hospices Civils de Lyon at 1 site in France.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jul 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Vouillarmet (4-78-86-14-89 ext. +33, julien.vouillarmet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of incidence of diabetic foot ulcer (time frame: At any time during a 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2021.