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Completed

NCT Number: NCT02405767

BioimPEDance of Diabetic Foot Ulcers

The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diabetic patient (Type 1 or 2) with diabetic foot ulcer or lower limb ulcer
  • written informed consent signed
  • insured by the French national health insurance scheme

Exclusion criteria

  • wound in the similar position on the other limb
  • people under legal protection
  • unilateral limb oedema
  • contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses
  • patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.

Treatment and study plan

Foot ulcer impedance

Other

lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).

Primary outcomes

  1. Change in impedance

    Time frame: 3 months

    Correlation between electrical impedance of the wound measured with ECG electrodes placed at the periphery of the wound and changes in the size of the wound and the clinically observed stage of healing.

Secondary outcomes

  1. Impedance of different wound tissues

    Time frame: 3 months

    Characteristic impedance of different types of wound tissue

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Commissariat A L'energie Atomique

Registry information

Official study title

Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers

Acronym: BIPPED

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2015
Registry last updated
May 10, 2017

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.

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