Clinical Trials Logo
  1. Home
  2. Diabetic Foot Ulcer
  3. NCT02405767
  4. Details
NCT02405767 Clinical Trial

BioimPEDance of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— BIPPED  

Official title:
Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02405767
Other study ID # Grenoble University Hospital.
Secondary ID 2015-A00070-49
Status Completed
Phase N/A
First received March 27, 2015
Last updated May 9, 2017
Start date April 2015
Est. completion date September 2, 2016

Study information
Verified date May 2017
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2, 2016
Est. primary completion date September 2, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Foot ulcer impedance
lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).

Locations
Country Name City State
France Grenoble University Hospital Grenoble

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Grenoble French Alternative Energies and Atomic Energy Commission - Grenoble

Country where clinical trial is conducted

France, 

References & Publications (1)

Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Impedance of different wound tissues Characteristic impedance of different types of wound tissue 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT04497805 - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers Phase 2
Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06439667 - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Not yet recruiting NCT06437028 - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers. N/A
Withdrawn NCT05024656 - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers N/A
Terminated NCT02202668 - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers N/A
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A