Bioimpedance for Injury

Overseen By Holly B Symonds

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Metatarsal fractures, Implanted devices, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging method called bioimpedance imaging for individuals with severe arm or leg injuries. The goal is to evaluate how effectively this imaging system can assist doctors in understanding and treating these injuries. The trial focuses on participants who have experienced a high-energy fracture to an arm or leg. Those with such a fracture and without an implanted electronic device, such as a pacemaker, might be suitable candidates for this study. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the EIT device is safe for imaging high-energy extremity trauma?

Research has shown that bioimpedance imaging is gaining popularity in healthcare. This technique uses electrical signals to gather information about the body's structure and functions. It is generally well-tolerated, as it doesn't involve radiation or invasive procedures, making it safer than some other imaging methods.

Although specific safety data from sources is not available, its use in assessing various conditions suggests safety. The trial's advanced stage indicates that the treatment has demonstrated a reasonable level of safety in previous applications. While no treatment is without risks, bioimpedance imaging is considered safe for most people based on its current uses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bioimpedance imaging for extremity fractures because it offers a non-invasive way to assess injuries. Unlike traditional X-rays or MRIs, which require exposure to radiation or costly equipment, bioimpedance imaging uses electrical signals to gather information about the body's tissues. This method could potentially allow for quicker and more frequent assessments of fracture healing, providing real-time feedback without the need for repeated hospital visits. Additionally, it may help identify complications earlier, leading to more personalized and efficient treatment plans for patients.

What evidence suggests that this EIT device is effective for extremity trauma?

Research has shown that bioimpedance imaging, which participants in this trial will experience, offers a promising method for monitoring bone healing. Studies indicate that it can easily and non-invasively track the healing of broken or lengthened bones. Like X-rays, it estimates bone mass and mineral content, but without radiation exposure. Additionally, bioimpedance devices are portable, making them convenient for use in emergency rooms or clinics. This technology's consistent measurement of changes aids doctors in assessing bone healing after serious injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Ida L Gitajn, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a high-energy closed fracture in one limb. They must be able to give informed consent. It's not for those with injuries to both lower limbs, implanted electronic devices, or pregnant/lactating women.

Inclusion Criteria

I have a severe break in a limb bone.

Provision of informed consent

Exclusion Criteria

I have injuries to both legs that prevent imaging of the opposite side.

I have a broken bone in my foot.

Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Patients undergo imaging with an EIT device in various clinical settings

20 minutes per session

Multiple sessions in Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioimpedance Imaging

Trial Overview

The study tests an electrical impedance tomography (EIT) device on patients with severe limb injuries. The EIT imaging will be done in various settings like the ER, operating room, orthopedic clinic, and hospital rooms.

How Is the Trial Designed?

Group I: Extremity fracture Experimental Treatment 1 Intervention

High energy closed extremity fractures

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9010194/

Bone Healing Monitoring in Bone Lengthening Using ...

Impedance is expected to be used to monitor fractured or lengthened bones in a noninvasive, low-cost, portable, and straightforward manner.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0972978X24004045

Could point-of-care bioimpedance analysis be another tool ...

Bioimpedance analysis (BIA) is a non-invasive, safe and portable technology, which can provide a calculated estimate of bone mass.

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1155/2022/3226440

Bone Healing Monitoring in Bone Lengthening Using ...

Bone impedance is a noninvasive, quantitative method of assessing bone fracture healing. The purpose of this study was to monitor bone healing ...

4.

nature.com

nature.com/articles/s41598-025-08304-8

Bioelectrical impedance analysis of bone mineral content ...

This study aimed to evaluate the consistency of bioelectrical impedance analysis (BIA) compared with dual-energy X-ray absorptiometry (DXA) for assessing BMC ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9210418/

Reliability of Multifrequency Bioelectrical Impedance ...

The purpose of this study was to assess inter-rater and intra-rater reliability of a portable bioelectrical impedance analysis (BIA) device to measure body ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11915145/

Biomechanical perspectives on image-based hip fracture ...

These imaging modalities provide critical data on bone mineral density, and material composition, which are essential for estimating femoral ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S127977072301463X

Bioelectrical impedance analysis is more accurate than ...

Bioelectrical impedance analysis is more accurate than clinical examination in determining the volaemic status of elderly patients with fragility fracture and ...

8.

biorxiv.org

biorxiv.org/content/10.1101/622936v1.full-text

Bone Fracture Detection by Electrical Bioimpedance

The results obtained show wide differences in the Cole Cole diagrams of both phantoms (entire and fractured bone), especially concerning the ...

9.

mdpi.com

mdpi.com/1424-8220/24/16/5321

Predicting the Healing of Lower Extremity Fractures Using ...

Integrating wearable sensors with machine learning can help overcome these challenges by providing objective assessment and predicting fracture healing.

10.

academia.edu

academia.edu/54951156/Bioimpedance_and_Bone_Fracture_Detection_A_State_of_the_Art?hb-sb-sw=47248919

Bioimpedance and Bone Fracture Detection: A State of the ...

Bioimpedance measurements are used increasingly in health applications because bioelectric parameters have been associated with anatomical and physiological ...