BioimPEDance of Diabetic Foot Ulcers
BIPPED
Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2016
CompletedMay 10, 2017
May 1, 2017
1.4 years
March 27, 2015
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
Impedance of different wound tissues
3 months
Study Arms (1)
Foot ulcer impedance
EXPERIMENTALDiabetic patients with a diabetic foot ulcer
Interventions
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- Commissariat A L'energie Atomiquecollaborator
Study Sites (1)
Grenoble University Hospital
Grenoble, 38043, France
Related Publications (1)
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.
PMID: 22401341BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 1, 2015
Study Start
April 1, 2015
Primary Completion
September 2, 2016
Study Completion
September 2, 2016
Last Updated
May 10, 2017
Record last verified: 2017-05