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OpenTrials
Completed

NCT Number: NCT01963559

Cutaneous Microcirculation and Diabetic Foot

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lidocaine/prilocaine 1g (topical administration)

Drug

Cutaneous blood flow measurement using laser Doppler

Primary outcomes

  1. Cutaneous blood flow

    Time frame: Within 3 months after inclusion

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: M2P2

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.