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Pressure and Diabetic Foot (PIV & MPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03213093
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : June 26, 2018
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes and Risk of Diabetic Foot Ulcer Other: Measure of cutaneous microcirculation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Diabetic patients with a risk of diabetic foot ulcer Other: Measure 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

Primary Outcome Measures :
  1. the rate of incidence of diabetic foot ulcer [ Time Frame: At any time during a 3 years follow-up ]
    A diabetic foot ulcer is defined as a breakdown in the skin under malleolus

Secondary Outcome Measures :
  1. Neurovascular response to pressure [ Time Frame: At the end of the 3-year follow-up ]
    Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18 years
  • Type 2 diabetic subject
  • Absence of active diabetic foot ulcer
  • Patients "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03213093

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Contact: Julien Vouillarmet 4-78-86-14-89 ext +33

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service d'endocrinologie, Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Julien VOUILLARMET, MD   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03213093     History of Changes
Other Study ID Numbers: 69HCL16_0168
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Diabetic Foot Ulcer
Plantar pressure

Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases