Pressure and Diabetic Foot (PIV & MPP)

Civil Hospices of Lyon

Status

Enrolling

Conditions

Diabetes and Risk of Diabetic Foot Ulcer

Treatments

Other: Measure of cutaneous microcirculation

Study type

Interventional

Funder types

Other

Identifiers

NCT03213093

69HCL16_0168

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)