BioimPEDance of Diabetic Foot Ulcers

NCT ID: NCT02405767

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-09-02

Brief Summary

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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

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Foot ulcer impedance

Diabetic patients with a diabetic foot ulcer

Group Type EXPERIMENTAL

Foot ulcer impedance

Intervention Type OTHER

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

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grenoble University Hospital

Grenoble, , France

Site Status

Countries

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France

References

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Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. doi: 10.1177/193229681200600126.

Reference Type BACKGROUND
PMID: 22401341 (View on PubMed)

Other Identifiers

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2015-A00070-49

Identifier Type: OTHER

Identifier Source: secondary_id

Grenoble University Hospital.

Identifier Type: -

Identifier Source: org_study_id

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