Pressure and Diabetic Foot (PIV & MPP)

July 23, 2021 updated by: Hospices Civils de Lyon

Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Age >18 years
  • Type 2 diabetic subject
  • Absence of active diabetic foot ulcer
  • Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
  • absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At any time during a 3 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 3-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0168

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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