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NCT02405767 Clinical Trial

BioimPEDance of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— BIPPED  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02405767
Other study ID # Grenoble University Hospital.
Secondary ID 2015-A00070-49
Status Completed
Phase N/A
First received March 27, 2015
Last updated May 9, 2017
Start date April 2015
Est. completion date September 2, 2016

Study information
Verified date May 2017
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2, 2016
Est. primary completion date September 2, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Foot ulcer impedance
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).

Locations
Country Name City State
France Grenoble University Hospital Grenoble

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Grenoble French Alternative Energies and Atomic Energy Commission - Grenoble

Country where clinical trial is conducted

France, 

References & Publications (1)

Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in impedance 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. 3 months
Secondary Impedance of different wound tissues Characteristic impedance of different types of wound tissue 3 months
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