BioimPEDance of Diabetic Foot Ulcers (BIPPED)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Other: Foot ulcer impedance

Study type: Interventional

Funder types: Other

Identifiers

NCT02405767

2015-A00070-49 (Other Identifier)

Grenoble University Hospital.

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Foot ulcer impedance

Experimental group

Description:

Diabetic patients with a diabetic foot ulcer

Treatment:

Other: Foot ulcer impedance