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Transient Thermal Behavior and Diabetic Foot (PICOTE)

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.
 
ClinicalTrials.gov Identifier: NCT03872089
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
LMGC - UMR 5508 - CNRS - Université de Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.

Condition or disease Intervention/treatment Phase
Diabetic Patients Type 1 and 2 Podologic Grade From 0 to 3 Other: Infrared Thermography Not Applicable

Detailed Description:
Both plants of the patient's feet will be observed by a thermal camera. Static observations (taking a single image), or dynamic (taking a series of images) of the foot, will be made. In the latter case, the observation will be done after a brisk walk of 6 min. The instruction given to patients will be to go the furthest in 3 min and then come back in 3 min, all while walking. The observation will be made by cameras without contact. These thermal cameras are non-invasive and non-ionizing, there is no risk related to their use. The camera will be placed on a tripod, a few tens of centimeters from the foot, and connected to a laptop (for the images acquisition). A wooden box, painted black, will be placed around both feet to protect the scene from parasitic thermal radiation that can disturb temperature variations. Foam will protect the skin / wood interface. Electric resistances, fixed on the box, will be placed in the field of vision of the thermal camera to guarantee the good treatment of the images. These resistors will never be in contact with the patient. The area filmed by the camera will be limited to the sole arch and, sometimes, the hand of patients to see if a thermal anomaly is also present on this member.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transient Thermal Behavior and Diabetic Foot
Estimated Study Start Date : March 19, 2019
Estimated Primary Completion Date : September 19, 2019
Estimated Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study participants
Measurements of the temperature of the plantar arch by thermal imaging. Result analysis regarding podologic grade ( 0-1-2-3)
Other: Infrared Thermography
Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)




Primary Outcome Measures :
  1. Thermal signals measured on plantar foot [ Time Frame: At the inclusion ]
    Determine the transient thermal responses at the plantar foot

  2. Correlation with podologic grade [ Time Frame: At the inclusion ]

    The classification of foot risk, mentioned in 2007 in the HAS report, is as follows ([HAS 2007]) Diabetic Foot Report http://www.has-sante.fr/portail/upload/docs/application/pdf/_foot_diabetic.pdf, 2007 :

    • Grade 0: absence of sensitive neuropathy Grade 1: isolated sensitive neuropathy
    • Grade 2: sensitive neuropathy associated with arteriopathy of the lower limbs and/or foot deformities
    • Grade 3: history(s) of foot ulceration (grade3a) and/or lower limb amputation (grade 3b)



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
Criteria

Inclusion Criteria:

  • Diabetic subjects (type 1 and 2)
  • age above 18 years old
  • able to walk
  • affiliate to insurance regimen

Exclusion Criteria:

  • unable to stay motionless
  • pregnancy
  • subjects with feet wound

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 ClinicalTrials.gov identifier (NCT number): NCT03872089


Contacts
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Contact: Ariane Sultan, MD-PhD 0467338402 a-sultan@chu-montpellier.fr

Sponsors and Collaborators
University Hospital, Montpellier
LMGC - UMR 5508 - CNRS - Université de Montpellier
Investigators
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Principal Investigator: Ariane Sultan, MD-PhD Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03872089    
Other Study ID Numbers: RECHMPL18_0371
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
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 University Hospital, Montpellier:
Infrared Thermography
Diabetic foot
Six minutes walking test
Microcirculation
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies