Pressure and Diabetic Foot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes and Risk of Diabetic Foot Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Diabetic patients with a risk of diabetic foot ulcer

Group Type OTHER

Measure of cutaneous microcirculation

Intervention Type OTHER

Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine

Interventions

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Measure of cutaneous microcirculation

Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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"
* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No