Diagnoses DiseaseNCT03313999
Measuring Skin Elasticity in Lymphedema Patients
A study testing Lymphedema Indentometer in people with Diagnoses Disease and Lymphedema, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnoses Disease, Lymphedema
- What is being tested?
- Lymphedema Indentometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2018to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients evaluated by the Beth Israel Deaconess Medical Center Lymphedema team with a diagnosis of lymphedema OR determined to be at risk of developing Lymphedema in any of their extremities
- Patients must be over 18 years of age
- Patients must be willing and capable to provide informed consent
- Patients must speak English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- Diagnoses Disease, Lymphedema
- Being tested
- Lymphedema Indentometer
- Keywords
- Lymphedema indentometer, Durometer
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphedema IndentometerDevice
Also called Durometer
The subject will sit down. The machine will be placed over their extremity/affected region. They will then be told the machine will be activated. They may or may not feel the machine touch them. 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 time during these 4 seconds. The entire procedure will take about a minute or less, after which the standard of care visit with the physical therapist will continue.
| Study group | Role | What they receive |
|---|---|---|
| Durometer Measurement | Other | 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. Receives: Device: Lymphedema Indentometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durometer Measurement
Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.
Measured: Enrollment (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start18 Feb 2018
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Why it stopped: Device was unable to be serviced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhruv Singhal, Beth Israel Deaconess Medical Center
- Investigators
- Dhruv Singhal, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313999
- Sponsor's protocol ID
- 2024P000442
- Status last verified
- Oct 2025
- First submitted
- 14 Oct 2017
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data from this study's data repository may be accessed by investigators interested in using the repository for research purposes. To access the data, investigator(s) will need to obtain Institutional Review Board approval of their protocol and submit their protocol to Dhruv Singhal, MD for review. Dr. Singhal will review the request for feasibility, scientific validity, and proper regulatory approvals. Only once the investigator(s) have received written Institutional Review Board approval, written approval from Dr. Singhal, and, if necessary, completed a material transfer agreement will they be given access to data from the repository. Dr. Singhal is uniquely suited to review requests to use repository data as he is a pioneer in the study and treatment of lymphedema and familiar with all information contained in the database.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Skin Elasticity in Lymphedema Patients
- ClinicalTrials.gov ID
- NCT03313999
- Acronym / sponsor ID
- 2024P000442
- Conditions
- Diagnoses Disease, Lymphedema
- Keywords
- Lymphedema indentometer, Durometer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device was unable to be serviced
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durometer Measurement | Other | Device: Lymphedema IndentometerAll 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients evaluated by the Beth Israel Deaconess Medical Center Lymphedema team with a diagnosis of lymphedema OR determined to be at risk of developing Lymphedema in any of their extremities
- Patients must be over 18 years of age
- Patients must be willing and capable to provide informed consent
- Patients must speak English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphedema IndentometerAlso: DurometerThe subject will sit down. The machine will be placed over their extremity/affected region. They will then be told the machine will be activated. They may or may not feel the machine touch them. 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 time during these 4 seconds. The entire procedure will take about a minute or less, after which the standard of care visit with the physical therapist will continue. | Device | Durometer Measurement |
Primary outcome
Durometer Measurement
Time frame: Enrollment (3 years)
Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.
Results and safety
The study was stopped early (reason given: Device was unable to be serviced). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: Yes. Data from this study's data repository may be accessed by investigators interested in using the repository for research purposes. To access the data, investigator(s) will need to obtain Institutional Review Board approval of their protocol and submit their protocol to Dhruv Singhal, MD for review. Dr. Singhal will review the request for feasibility, scientific validity, and proper regulatory approvals. Only once the investigator(s) have received written Institutional Review Board approval, written approval from Dr. Singhal, and, if necessary, completed a material transfer agreement will they be given access to data from the repository. Dr. Singhal is uniquely suited to review requests to use repository data as he is a pioneer in the study and treatment of lymphedema and familiar with all information contained in the database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhruv Singhal, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphedema Indentometer in people with Diagnoses Disease and Lymphedema, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Device was unable to be serviced). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durometer Measurement (time frame: Enrollment (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.