- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405767
BioimPEDance of Diabetic Foot Ulcers (BIPPED)
May 9, 2017 updated by: University Hospital, Grenoble
Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Grenoble, France, 38043
- Grenoble University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Foot ulcer impedance
Diabetic patients with a diabetic foot ulcer
|
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in impedance
Time Frame: 3 months
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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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impedance of different wound tissues
Time Frame: 3 months
|
Characteristic impedance of different types of wound tissue
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
September 2, 2016
Study Completion (Actual)
September 2, 2016
Study Registration Dates
First Submitted
March 27, 2015
First Submitted That Met QC Criteria
March 31, 2015
First Posted (Estimate)
April 1, 2015
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 9, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grenoble University Hospital.
- 2015-A00070-49 (Other Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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