Transient Thermal Behavior and Diabetic Foot

NCT03872089 | Terminated

• 1 other identifier: RECHMPL18_0371
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Patients Type 1 and 2; Podologic Grade From 0 to 3

Keywords

Infrared Thermography; Diabetic foot; Six minutes walking test; Microcirculation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Study participants

EXPERIMENTAL

Measurements of the temperature of the plantar arch by thermal imaging. Result analysis regarding podologic grade ( 0-1-2-3)

Other: Infrared Thermography

Interventions

Infrared Thermography OTHER

Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

CHU Montpellier - Lapeyronie hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Ariane Sultan, MD-PhD

  Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 13, 2019
• Study Start: April 8, 2019
• Primary Completion: October 8, 2019
• Study Completion: April 8, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)