Transient Thermal Behavior and Diabetic Foot (PICOTE)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Patients Type 1 and 2; Podologic Grade From 0 to 3
• Intervention / Treatment: Other: Infrared Thermography

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier - Lapeyronie hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal signals measured on plantar foot	Determine the transient thermal responses at the plantar foot	At the inclusion
Correlation with podologic grade	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)	At the inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier
• Investigators: Principal Investigator: Ariane Sultan, MD-PhD, Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Diabetic foot; Microcirculation; Infrared Thermography; Six minutes walking test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: RECHMPL18_0371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No