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BioimPEDance of Diabetic Foot Ulcers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02405767
Acronym
BIPPED
Enrollment
20
Registered
2015-04-01
Start date
2015-04-30
Completion date
2016-09-02
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic foot ulcer

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.

Interventions

OTHERFoot 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).

Sponsors

Commissariat A L'energie Atomique
CollaboratorOTHER_GOV
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in impedance3 monthsCorrelation 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

MeasureTime frameDescription
Impedance of different wound tissues3 monthsCharacteristic impedance of different types of wound tissue

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026