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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.

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 data supports the effectiveness of the treatment Skin Elasticity Measurement for lymphedema?

Research shows that measuring skin elasticity can help track the progression of lymphedema, as changes in skin elasticity are linked to the severity of the condition. This suggests that monitoring skin elasticity could be a useful tool in managing lymphedema. ^{1 2 3 4 5}

How does the Skin Elasticity Measurement treatment differ from other treatments for lymphedema?

The Skin Elasticity Measurement treatment is unique because it uses a noninvasive method to assess skin elasticity and induration (hardness) in lymphedema patients, providing a quantitative way to monitor disease progression and treatment effects, unlike traditional methods that rely on physical examination or self-reporting. ^{1 4 5 6 7}

Research Team

Dhruv Singhal, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

I am over 18 years old.

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 willing and able to agree to participate in the study.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of breast cancer-related arm lymphedema--comparison of physical measurement methods and self-report. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Biomechanical Properties of the Skin in Patients with Breast Cancer-Related Lymphedema Compared to Healthy Individuals. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a telephone questionnaire to characterize lymphedema in women treated for breast cancer. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

Real-time tissue elastography assessment of skin and subcutaneous tissue strains in legs with lymphedema. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Development of a Noninvasive Skin Evaluation Method for Lower Limb Lymphedema. [2021]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Study of cutaneous extensibility in lymphoedema of the lower limbs. [2019]