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Measuring Skin Elasticity in Lymphedema Patients

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ClinicalTrials.gov Identifier: NCT03313999
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dhruv Singhal, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE October 14, 2017
First Posted Date  ICMJE October 19, 2017
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE February 18, 2018
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2017)
Durometer Measurement [ Time Frame: Enrollment (3 years) ]
Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03313999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring Skin Elasticity in Lymphedema Patients
Official Title  ICMJE Measuring Skin Elasticity in Lymphedema Patients
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diagnoses Disease
  • Lymphedema
Intervention  ICMJE Device: Lymphedema Indentometer
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.
Other Name: Durometer
Study Arms  ICMJE Durometer Measurement
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.
Intervention: Device: Lymphedema Indentometer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2017)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dhruv Singhal, MD 617-632-7855 dsinghal@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03313999
Other Study ID Numbers  ICMJE 2017P-000378
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: Researchers will only have access to information in the study's database for the duration of their Institutional Review Board approval.
Access Criteria: After the interested investigator(s) receive Institutional Review Board approval and approval from Dr. Singhal, the study team will securely send the data to the requesting investigator. Any requesting investigator will receive only durometer measurements, lymphedema characteristics and demographic information from the database. In all cases the requesting investigator will receive only de-identified data.
Responsible Party Dhruv Singhal, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dhruv Singhal, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP