BioimPEDance of Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Other: Foot ulcer impedance

• Registration Number: NCT02405767
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-31
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Primary Completion: 2016-09-02
• Study Completion: 2016-09-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Foot ulcer impedance	Foot ulcer impedance	Diabetic patients with a diabetic foot ulcer

Primary Outcome Measures

Name	Time	Method
Change in impedance	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 Outcome Measures

Name	Time	Method
Impedance of different wound tissues	3 months	Characteristic impedance of different types of wound tissue

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France