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Cutaneous Microcirculation and Diabetic Foot (M2P2)

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ClinicalTrials.gov Identifier: NCT01963559
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Proned Patients Drug: Lidocaine/prilocaine 1g (topical administration) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cutaneous Microcirculation and Diabetic Foot
Study Start Date : April 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prilocaine

Arms and Interventions
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Arm Intervention/treatment
Diabetic patients with MPP Drug: Lidocaine/prilocaine 1g (topical administration)
Cutaneous blood flow measurement using laser Doppler
Diabetic patients without MPP Drug: Lidocaine/prilocaine 1g (topical administration)
Cutaneous blood flow measurement using laser Doppler


Outcome Measures
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Primary Outcome Measures :
  1. Cutaneous blood flow [ Time Frame: Within 3 months after inclusion ]

Secondary Outcome Measures :
  1. Effect of neuropathy on PIV impairment [ Time Frame: Within 3 months after inclusion ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No signed acknowledgement form
  • patients under 18 year-old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963559


Locations
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France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01963559    
Other Study ID Numbers: 2011.661
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Lidocaine
Prilocaine
 Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined