Pressure and Diabetic Foot

Study Overview
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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.

Official Title
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Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes

Conditions
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Diabetes and Risk of Diabetic Foot Ulcer

Intervention / Treatment
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* Other: Measure of cutaneous microcirculation


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetic patients with a risk of diabetic foot ulcer<br> | Other: Measure of cutaneous microcirculation<br>* Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of incidence of diabetic foot ulcer | A diabetic foot ulcer is defined as a breakdown in the skin under malleolus | At any time during a 3 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurovascular response to pressure | Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit. | At the end of the 3-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Diabetic Foot Ulcer, Plantar pressure