Pressure and Diabetic Foot

  • STATUS
    Recruiting
  • End date
    Mar 2, 2026
  • participants needed
    200
  • sponsor
    Hospices Civils de Lyon
Updated on 2 August 2021

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.

Details
Condition Diabetes and Risk of Diabetic Foot Ulcer
Treatment Measure of cutaneous microcirculation
Clinical Study IdentifierNCT03213093
SponsorHospices Civils de Lyon
Last Modified on2 August 2021

Eligibility

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
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 mol.l-1)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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