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RecruitingNot ApplicableNCT03213093

Pressure and Diabetic Foot

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

Sponsor

Hospices Civils de Lyon

Enrollment

200 participants

Start Date

Dec 1, 2017

Study Type

INTERVENTIONAL

Conditions

Diabetes and Risk of Diabetic Foot Ulcer

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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)

Interventions

OTHERMeasure 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

Locations(1)

service d'endocrinologie, Centre Hospitalier Lyon Sud

Pierre-Bénite, France

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NCT03213093