Diabetic Foot Ulcer
Conditions
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
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Impedance of different wound tissues | 3 months | Characteristic impedance of different types of wound tissue |
Countries
France