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Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health (DoD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927404
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Chandan Sen, Indiana University

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
Residual limb health at 16 weeks after use [ Time Frame: 16 Weeks ]
Change from baseline in overall limb health in 16 wks
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Residual limb health across elevated vacuum system (EVS) and SoC socket [ Time Frame: 16 Weeks ]
Change from baseline in overall limb health in 16 wks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
  • Hyperspectral Imaging at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Hyperspectral Imaging at 16 wks
  • Laser speckle flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
  • TEWL measurement at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Transepidermal Water Loss (TEWL) value in 16 wks
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
  • Hyperspectral Imaging at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Hyperspectral Imaging at 16 wks
  • Laser speckle flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
  • TEWL measurement at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in TEWL value in 16 wks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
Official Title  ICMJE Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
Brief Summary

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.

The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

Detailed Description

There are a total of 3 study visits, including socket fitting visits, a baseline visit, and a final visit. During the socket visit, which may consist of a three visits plus socket adjustments (as needed by the participant) on separate days (up to 4 weeks), limb shape capture, measurement or tracing, diagnostic static fitting and diagnostic static fitting, and delivery of a definitive "research" socket will be done. At the baseline visit, participants will perform seated tasks, standing tasks, and treadmill walking tasks. Residual limb health measurements will be taken before and after the activity period, including surface electrical capacitance, Transepidermal Water Loss (TEWL) measurement, hyperspectral imaging, Hitachi Aloka ultrasound imaging, Laser Speckle Imaging (LSI)/Blood Flow, and digital imaging during the baseline visit as well. The final visit, using the research socket, will consist of the same tasks and measurements as the baseline visit.

After completion of the study, participants will be given the choice to keep the research socket or return to using their original prosthesis as normal. The study prosthetist will be available to review and adjust the fit of their standard of care prosthesis at this time. Note: Due to physical change and limb volume fluctuation over the study period, it is possible that at the end of the study the standard of care prosthesis will not fit your residual limb as it does at the beginning of the study. At the completion of the study, it is recommended that the subject follow up with their primary care prosthetist for socket evaluation and fitting.

There may be risks that are not known about at this time. Side effects, risks, and discomforts may result from study participation.

  • Prosthesis placement: While the goal of this project is to create a more comfortable prosthesis, it is possible that the subject could experience discomforts commonly associated with prosthesis use, such as perspiration, dry skin, rash, itching, blisters, high pressure in the socket, looseness in the socket, and mechanical rubbing that leads to ulceration.
  • Treadmill task:There is a risk of falling during the research activities. This risk is mitigated by the ability of participants to self-select pace for the treadmill task and observation of treadmill activities by research staff.
  • Transcutaneous Oxygen Measurement (TcOM) and skin temperature: The PeriFlux System 5000 uses non-invasive probes that will measure the skin temperature and transcutaneous Oxygen Measurement and poses minimal risk to the subject. The probe head is affixed to the residual limb by an adhesive sticker. Removal of the sticker after data acquisition may cause minor discomfort similar to removing a small band-aid.
  • Hyperspectral Imaging: This non-invasive imaging technique poses minimal risk to the subject. A small fiduciary marker sticker is placed on the subject's limb to calibrate camera settings. Removal of the sticker after imaging may cause minor discomfort similar to removing a small band-aid.
  • Laser Speckle Imaging (LSI): LSI is a non-invasive blood flow imaging technique. Laser speckle imaging is very routinely used for blood perfusion measurement in clinical applications. We do not anticipate any radiation exposure. Laser applications such as for LSI for diagnostic purposes are of Class 1 (<0.4 mW) are considered harmless for the eye and skin."
  • Hitachi Aloka Ultrasound:Ultrasound imaging is a noninvasive technique and is a minimal risk procedure.
  • TEWL and Surface Electrical Capacitance Measurements: TEWL and Surface Electrical Capacitance measurements are noninvasive and propose less than minimal risk.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a 16 weeks longitudinal study where subjects will serve their own control. A baseline measurement will be done prior to start of intervention that will continue for 16 weeks and a final measurement will be taken at the end of 16 weeks.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Lower Limb Amputation
Intervention  ICMJE Device: Active vacuum test prosthesis
The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Other Name: Limb logic system
Study Arms  ICMJE Experimental: Adaptive Vacuum test Prosthesis
The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Intervention: Device: Active vacuum test prosthesis
Publications *

*   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: January 21, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
60
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages of 18 and above
  • Unilateral transtibial or transfemoral amputee
  • Ambulate at a K2 level or higher
  • At least 3 months post-amputation per physician discretion
  • Residual limb length greater than 6.5 inches in length
  • Able to follow directions and give informed consent on their own
  • Must be able to ambulate without assistance
  • Adequate arterial blood flow as evidenced by a TcOM >30mmHg

Exclusion Criteria:

  • Conditions that prevent wearing a prosthetic socket
  • Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
  • Women who are pregnant or who plan to become pregnant in the near future
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Mohnacky, RDN (317)-278-2715 jmohnack@iu.edu
Contact: Tammy Garrett, RN (317) 278-2716 tjgarret@iupui.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927404
Other Study ID Numbers  ICMJE 1809327674
W81XWH-16-2-0059 ( Other Grant/Funding Number: DoD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chandan Sen, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Chandan Sen, PhD Indiana University
PRS Account Indiana University
Verification Date February 2020

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