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Cutaneous Microcirculation and Diabetic Foot (M2P2)

Primary Purpose

Diabetic Foot Proned Patients

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lidocaine/prilocaine 1g (topical administration)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetic Foot Proned Patients

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • No signed acknowledgement form
  • patients under 18 year-old

Sites / Locations

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diabetic patients with MPP

Diabetic patients without MPP

Arm Description

Outcomes

Primary Outcome Measures

Cutaneous blood flow

Secondary Outcome Measures

Effect of neuropathy on PIV impairment
Difference in skin vascular response to local application of pressure (PIV) with and without topical application of a local anesthetic cream Lidocaine / prilocaine in all diabetic patients (with and without MPP).

Full Information

First Posted
October 10, 2013
Last Updated
November 21, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01963559
Brief Title
Cutaneous Microcirculation and Diabetic Foot
Acronym
M2P2
Official Title
Cutaneous Microcirculation and Diabetic Foot
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Proned Patients

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patients with MPP
Arm Type
Other
Arm Title
Diabetic patients without MPP
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Lidocaine/prilocaine 1g (topical administration)
Intervention Description
Cutaneous blood flow measurement using laser Doppler
Primary Outcome Measure Information:
Title
Cutaneous blood flow
Time Frame
Within 3 months after inclusion
Secondary Outcome Measure Information:
Title
Effect of neuropathy on PIV impairment
Description
Difference in skin vascular response to local application of pressure (PIV) with and without topical application of a local anesthetic cream Lidocaine / prilocaine in all diabetic patients (with and without MPP).
Time Frame
Within 3 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Men and Women Presence of diabetes Signed acknowledgement form Exclusion Criteria: No signed acknowledgement form patients under 18 year-old
Facility Information:
Facility Name
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

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Cutaneous Microcirculation and Diabetic Foot

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