PICOTE: Transient Thermal Behavior and Diabetic Foot

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Terminated
CT.gov ID
NCT03872089
Collaborator
Université Montpellier (Other)
45
1
1
12
3.7

Study Details

Study Description

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
  • Other: Infrared Thermography
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Transient Thermal Behavior and Diabetic Foot
Actual Study Start Date :
Apr 8, 2019
Actual Primary Completion Date :
Oct 8, 2019
Actual Study Completion Date :
Apr 8, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Thermal signals measured on plantar foot [At the inclusion]

    Determine the transient thermal responses at the plantar foot

  2. Correlation with podologic grade [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Montpellier - Lapeyronie hospital Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier
  • Université Montpellier

Investigators

  • Principal Investigator: Ariane Sultan, MD-PhD, Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03872089
Other Study ID Numbers:
  • RECHMPL18_0371
First Posted:
Mar 13, 2019
Last Update Posted:
Dec 30, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2021