Lymphedema Indentometer for Lymphedema
Recruiting in Palo Alto (17 mi)
Overseen byDhruv Singhal, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
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.
12345How 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.
14567Eligibility 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.
Patients must speak English
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.
+1 more
Exclusion Criteria
Not applicable.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Durometer MeasurementExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical CenterLead Sponsor
References
Assessment of breast cancer-related arm lymphedema--comparison of physical measurement methods and self-report. [2022]To determine the relationship between physical methods of measuring lymphedema and self-reported swelling, their reliability, and standard error of measurement.
Biomechanical Properties of the Skin in Patients with Breast Cancer-Related Lymphedema Compared to Healthy Individuals. [2015]Biomechanical skin changes in breast cancer-related lymphedema (BRCL) have barely been described and objectively tested. This study aims to compare the skin of upper limb lymphedema with skin of the healthy contralateral arm, in order to demonstrate changes of elasticity, viscoelasticity, and level of hydration of the skin in BCRL. The secondary aim is to investigate the correlation between biomechanical skin changes and measurements that are currently used in clinical practice, such as volume measurement and lymph-ICF score.
Development and validation of a telephone questionnaire to characterize lymphedema in women treated for breast cancer. [2021]Accurate and economical characterization of lymphedema is needed for population-based studies of incidence and risk. The purpose of this study was to develop and validate a telephone questionnaire for characterizing lymphedema.
Real-time tissue elastography assessment of skin and subcutaneous tissue strains in legs with lymphedema. [2018]To confirm the feasibility of assessing strains of the skin and subcutaneous tissue in normal legs and legs with lymphedema via free-hand real-time tissue elastography (RTE) using a phantom.
Development of a Noninvasive Skin Evaluation Method for Lower Limb Lymphedema. [2021]Background: The skin's condition is altered in lymphedema patients, and evaluating this change is important. Some noninvasive methods for evaluating skin condition have been reported, especially in upper limb lymphedema. However, evaluating the skin in lower limb lymphedema remains challenging and is often limited to palpation. We aimed to develop a noninvasive skin evaluation method for lower limb lymphedema patients. Methods and Results: Twenty-five lower limb lymphedema patients were included. Skin induration and elasticity were measured using Indentometer® IDM 400 and Cutometer® MPA580. The relationship between the properties of skin from the healthy forearm and thigh, those of the affected thigh, and age was analyzed. Predicted skin induration age (IA) and elasticity age (EA) were calculated from the forearm, whereas actual values were calculated from the thigh, and the differences (ΔIA and ΔEA) were assessed. Patients were classified according to the International Society of Lymphology clinical staging system, and the differences in ΔIA and ΔEA were analyzed among the three groups (healthy, stage I/IIa, and stage IIb/III). Skin biopsy was performed in five unilateral lower limb lymphedema patients, and the dermal elastic fiber area was determined using microscopy with Elastica van Gieson staining. ΔEA significantly increased with disease progression, but ΔIA did not change significantly. Microscopy revealed elastic fiber filamentous changes, with decreased elastic fiber areas in lymphedema-affected skin. Conclusion: To our knowledge, this is the first report to evaluate lower limb skin elasticity in lymphedema quantitatively and noninvasively. ΔEA is useful for evaluating skin condition progression in lymphedema patients.
Dermal thickness and echogenicity using DermaScan C high frequency ultrasound: Methodology and reliability testing in people with and without primary lymphoedema. [2021]DermaScan C high frequency ultrasound was investigated for image capture and analysis of dermal measures in people with and without primary lymphoedema.
Study of cutaneous extensibility in lymphoedema of the lower limbs. [2019]We have studied changes in the elasticity and viscosity of the skin in patients with lymphoedema, using a technique involving vertical extensibility by suction. We measured parameters which included immediate extensibility (Ue, which reflects the elastic properties of the skin), and delayed extensibility (Uv which reflects intracutaneous movements of a viscous type). In grade III lymphoedema, Ue is decreased and Uv is increased. These changes are explained by volume variations and histological alterations, and tend to normalize after treatment. Our study shows that measurement of extensibility is useful in evaluation of volume variations, effects of therapy, and disease evolution, as Ue variations correlate with volume variations and with Uv changes. This technique also provides information which is useful in assessing patients' functional difficulties in relation to skin infiltration, and might be of value in lymphoedema follow-up.