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Cutaneous Microcirculation and Diabetic Foot

NCT ID: NCT01963559

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.

Detailed Description

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Conditions

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Diabetic Foot Proned Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diabetic patients with MPP

Group Type OTHER

Lidocaine/prilocaine 1g (topical administration)

Intervention Type DRUG

Cutaneous blood flow measurement using laser Doppler

Diabetic patients without MPP

Group Type OTHER

Lidocaine/prilocaine 1g (topical administration)

Intervention Type DRUG

Cutaneous blood flow measurement using laser Doppler

Interventions

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Lidocaine/prilocaine 1g (topical administration)

Cutaneous blood flow measurement using laser Doppler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult Men and Women
* Presence of diabetes
* Signed acknowledgement form

Exclusion Criteria

* No signed acknowledgement form
* patients under 18 year-old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2011.661

Identifier Type: -

Identifier Source: org_study_id