Lymphedema Indentometer for Lymphedema

Overseen By Dhruv Singhal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand lymphedema using a new tool called the durometer, which measures skin elasticity. The researchers seek to track lymphedema progression and treatment effectiveness at Beth Israel Deaconess Medical Center. Participants will have their skin elasticity measured alongside their regular care. Individuals with lymphedema or at risk of developing it in their arms or legs, who receive treatment at this center, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance lymphedema care for many.

Will I have to stop taking my current medications?

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

What prior data suggests that this device is safe for measuring skin elasticity?

Research shows that checking skin elasticity is safe for people with lymphedema. A small device gently presses on the skin for a few seconds to assess its elasticity. Studies have found this method reliable and free from pain or harm. This tool helps doctors understand skin changes without any known side effects. Prospective trial participants can be reassured that this method is well-tolerated and poses little to no risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lymphedema Indentometer trial because it uses a durometer to measure skin elasticity, offering a new way to track lymphedema progression. Unlike traditional approaches that rely solely on visual assessments and limb circumference measurements, the durometer provides a more precise evaluation of skin stiffness. This could lead to earlier detection of changes in the condition and help tailor treatments more effectively, potentially improving patient outcomes and quality of life.

What evidence suggests that the lymphedema indentometer is effective for measuring skin elasticity in lymphedema?

Research shows that checking skin stretchiness can help in understanding lymphedema, a condition that causes swelling due to fluid build-up. In this trial, all participants will receive standard care for their lymphedema, and their skin will be measured using a durometer. Studies have found that a durometer, which measures skin stretchiness, reliably assesses skin properties. In people with lymphedema, this method helps evaluate treatment effectiveness in reducing swelling. By monitoring changes in skin stretchiness, doctors can better understand the condition's development and treatment efficacy. Overall, this approach provides useful insights into managing lymphedema by assessing skin response to therapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Dhruv Singhal, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adult patients at Beth Israel Deaconess Medical Center who have been diagnosed with lymphedema or are at risk of developing it. Participants must be over 18, speak English, and able to give informed consent.

Inclusion Criteria

You have been diagnosed with lymphedema by the Beth Israel Deaconess Medical Center Lymphedema team or have a risk of developing lymphedema in any of your limbs.

I am over 18 years old.

I am willing and able to agree to participate in the study.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment for lymphedema and are measured by the durometer to assess skin elasticity

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Skin Elasticity Measurement

Trial Overview The study is testing a new tool called the lymphedema indentometer. This device measures skin elasticity to track disease progression in lymphedema patients undergoing treatment.

How Is the Trial Designed?

Group I: Durometer Measurement Experimental Treatment 1 Intervention

All patients participating in the study will receive standard of care treatment for their lymphedema. As part of the study they will be measured by the durometer in addition to other, standard diagnostics to further characterize their lymphedema progression.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

The study successfully demonstrated that free-hand real-time tissue elastography (RTE) can be used to measure strains in skin and subcutaneous tissue, showing significant differences in strain between healthy tissue in 35 volunteers.

In patients with unilateral stage II lymphedema, the study found no significant differences in strain measurements between the affected and unaffected legs, suggesting that lymphedema may not alter the mechanical properties of the skin and subcutaneous tissue as measured by RTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time tissue elastography assessment of skin and subcutaneous tissue strains in legs with lymphedema. Suehiro, K., Nakamura, K., Morikage, N., et al.[2018]

The DermaScan C high frequency ultrasound demonstrated excellent intra-rater reliability for measuring dermal echogenicity in both people with primary lymphoedema (PLO) and those without lymphoedema (NLO), indicating it is a reliable tool for assessing skin properties.

Inter-session reliability was moderate in NLO but improved significantly in PLO after method adjustments, suggesting that careful calibration and technique are crucial for consistent results in different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal thickness and echogenicity using DermaScan C high frequency ultrasound: Methodology and reliability testing in people with and without primary lymphoedema. Phillips, J., Reynolds, KJ., Gordon, SJ.[2021]

In patients with grade III lymphoedema, skin elasticity (measured as immediate extensibility, Ue) decreases while skin viscosity (measured as delayed extensibility, Uv) increases, indicating significant changes in skin properties due to the condition.

The study demonstrates that measuring skin extensibility can effectively evaluate treatment outcomes and disease progression, as changes in Ue correlate with volume variations and can help assess patients' functional difficulties related to skin infiltration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of cutaneous extensibility in lymphoedema of the lower limbs. Auriol, F., Vaillant, L., Pelucio-Lopes, C., et al.[2019]

Physical methods for measuring lymphedema, such as bioimpedance spectroscopy and perometry, showed high reliability and concordance, indicating they are effective tools for assessing swelling in women with breast cancer-related lymphedema.

Self-reported swelling correlated moderately with physical measurements, suggesting that while self-reports can provide useful information, they should not replace physical measurement methods in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of breast cancer-related arm lymphedema--comparison of physical measurement methods and self-report. Czerniec, SA., Ward, LC., Refshauge, KM., et al.[2022]

A new noninvasive method was developed to quantitatively evaluate skin elasticity in lower limb lymphedema patients, involving 25 participants, which is a significant advancement over traditional palpation methods.

The study found that skin elasticity (ΔEA) significantly worsens with disease progression in lymphedema, while skin induration (ΔIA) remains stable, indicating that ΔEA can be a valuable measure for monitoring skin condition changes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Noninvasive Skin Evaluation Method for Lower Limb Lymphedema. Sano, M., Hirakawa, S., Yamanaka, Y., et al.[2021]

Patients with breast cancer-related lymphedema (BCRL) showed significantly impaired skin elasticity in the affected arm compared to the healthy arm, indicating a clear biomechanical change associated with the condition.

The study suggests that the Cutometer device could be a useful tool for diagnosing BCRL, as it effectively measures skin elasticity, which correlates with volume differences in lymphedema patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Properties of the Skin in Patients with Breast Cancer-Related Lymphedema Compared to Healthy Individuals. Killaars, RC., Penha, TR., Heuts, EM., et al.[2015]

A telephone questionnaire developed to assess lymphedema in women treated for breast cancer showed high sensitivity (0.93 to 0.96) for detecting any lymphedema, indicating it is a reliable tool for initial screening.

The questionnaire demonstrated excellent agreement with physical therapists' clinical assessments for identifying at least moderate lymphedema, with a weighted kappa of 0.80, suggesting it can be an effective and economical method for characterizing lymphedema in population studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a telephone questionnaire to characterize lymphedema in women treated for breast cancer. Norman, SA., Miller, LT., Erikson, HB., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297454/

Skin mechanical properties measured with skin elasticity ... This review aimed to provide an overview of studies measuring the skin mechanical properties of patients with lymphedema using a skin elasticity meter.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03313999

Measuring Skin Elasticity in Lymphedema Patients A small pressure will be applied to the skin surface for 4 seconds. The computer will record the skin elasticity as change in resistance to compression over ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/srt.12116

Measurement of skin thickness and skin elasticity to ... Measurement of skin thickness and skin elasticity to evaluate the effectiveness of intensive decongestive treatment in patients with lymphoedema ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12045608/

Reliability and validity of skin elasticity meter to measure ... [Purpose] This study aimed to clarify the reliability and validity of a skin elasticity meter for evaluating the skin mechanical properties.

5. researchgate.net researchgate.net/publication/391333626_Reliability_and_validity_of_skin_elasticity_meter_to_measure_skin_mechanical_properties_in_patients_with_lower_extremity_cancer-related_edema

(PDF) Reliability and validity of skin elasticity meter to ... [Conclusion] This study suggested that the skin elasticity meter is a reliable and valid method for evaluating the mechanical properties of the ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03313999/measuring-skin-elasticity-in-lymphedema-patients

Measuring Skin Elasticity in Lymphedema Patients This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity) ...