Pressure and Diabetic Foot

Not Applicable

Recruiting

• Conditions: Diabetes and Risk of Diabetic Foot Ulcer
• Interventions: Other: Measure of cutaneous microcirculation

• Registration Number: NCT03213093
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-12-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic patients with a risk of diabetic foot ulcer	Measure of cutaneous microcirculation	-

Primary Outcome Measures

Name	Time	Method
the rate of incidence of diabetic foot ulcer	At any time during a 3 years follow-up	A diabetic foot ulcer is defined as a breakdown in the skin under malleolus

Secondary Outcome Measures

Name	Time	Method
Neurovascular response to pressure	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.

Trial Locations

Locations (1)

service d'endocrinologie, Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France