Pressure and Diabetic Foot (PIV & MPP)

  • End date
    Mar 2, 2026
  • participants needed
  • sponsor
    Hospices Civils de Lyon
Updated on 4 March 2022


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.

Condition Diabetes and Risk of Diabetic Foot Ulcer
Treatment Measure of cutaneous microcirculation
Clinical Study IdentifierNCT03213093
SponsorHospices Civils de Lyon
Last Modified on4 March 2022


Yes No Not Sure

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
Congenital methemoglobinemia
Skin injured on the tibia, whatever the lesion
Recent major cardiovascular history (less than 3 months)
Severe renal disease (serum creatinine> 300 mol.l-1)
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