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Pressure and Diabetic Foot (PIV & MPP)

Primary Purpose

Diabetes and Risk of Diabetic Foot Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Measure of cutaneous microcirculation

About this trial

This is an interventional screening trial for Diabetes and Risk of Diabetic Foot Ulcer focused on measuring Diabetes, Diabetic Foot Ulcer, Plantar pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

service d'endocrinologie, Centre Hospitalier Lyon SudRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diabetic patients with a risk of diabetic foot ulcer

Arm Description

Outcomes

Primary Outcome Measures

the rate of incidence of diabetic foot ulcer

A diabetic foot ulcer is defined as a breakdown in the skin under malleolus

Secondary Outcome Measures

Neurovascular response to pressure

Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit.

Full Information

NCT ID

NCT03213093

First Posted

July 6, 2017

Last Updated

July 23, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT03213093

Brief Title

Pressure and Diabetic Foot

Acronym

PIV & MPP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

March 2026 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes and Risk of Diabetic Foot Ulcer

Keywords

Diabetes, Diabetic Foot Ulcer, Plantar pressure

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diabetic patients with a risk of diabetic foot ulcer

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Measure of cutaneous microcirculation

Intervention Description

Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine

Primary Outcome Measure Information:

Title

the rate of incidence of diabetic foot ulcer

Description

A diabetic foot ulcer is defined as a breakdown in the skin under malleolus

Time Frame

At any time during a 3 years follow-up

Secondary Outcome Measure Information:

Title

Neurovascular response to pressure

Description

Receiver Operating Characteristic (ROC) analysis for neurovascular response to predict foot ulcer. Results are expressed in arbitrary unit.

Time Frame

At the end of the 3-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julien Vouillarmet

Phone

4-78-86-14-89

Ext

+33

julien.vouillarmet@chu-lyon.fr

Facility Information:

Facility Name

service d'endocrinologie, Centre Hospitalier Lyon Sud

City

Pierre-Bénite

ZIP/Postal Code

69310

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julien VOUILLARMET, MD

julien.vouillarmet@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD

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Pressure and Diabetic Foot

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