Pressure and Diabetic Foot

NCT03213093 | Recruiting

• 1 other identifier: 69HCL16_0168
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes and Risk of Diabetic Foot Ulcer

Keywords

Diabetes; Diabetic Foot Ulcer; Plantar pressure

Outcome Measures

Primary Outcomes (1)

• the rate of incidence of diabetic foot ulcer

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

  At any time during a 3 years follow-up

Secondary Outcomes (1)

• Neurovascular response to pressure

  At the end of the 3-year follow-up

Study Arms (1)

Diabetic patients with a risk of diabetic foot ulcer

OTHER

Other: Measure of cutaneous microcirculation

Interventions

Measure of cutaneous microcirculation OTHER

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

Diabetic patients with a risk of diabetic foot ulcer

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

service d'endocrinologie, Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Central Study Contacts

Julien Vouillarmet

CONTACT

4-78-86-14-89; julien.vouillarmet@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: December 1, 2017
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)