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BioimPEDance of Diabetic Foot Ulcers (BIPPED)

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Foot ulcer impedance
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Foot Ulcer focused on measuring Diabetic foot ulcer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Grenoble University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Foot ulcer impedance

Arm Description

Diabetic patients with a diabetic foot ulcer

Outcomes

Primary Outcome Measures

Change in impedance
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

Impedance of different wound tissues
Characteristic impedance of different types of wound tissue

Full Information

First Posted
March 27, 2015
Last Updated
May 9, 2017
Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique
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1. Study Identification

Unique Protocol Identification Number
NCT02405767
Brief Title
BioimPEDance of Diabetic Foot Ulcers
Acronym
BIPPED
Official Title
Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2, 2016 (Actual)
Study Completion Date
September 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic foot ulcer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foot ulcer impedance
Arm Type
Experimental
Arm Description
Diabetic patients with a diabetic foot ulcer
Intervention Type
Other
Intervention Name(s)
Foot ulcer impedance
Intervention Description
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
Primary Outcome Measure Information:
Title
Change in impedance
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Impedance of different wound tissues
Description
Characteristic impedance of different types of wound tissue
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22401341
Citation
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.
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BioimPEDance of Diabetic Foot Ulcers

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