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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03927404

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted February 28, 2020

Study Description

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.

  • Condition or Disease:Lower Limb Amputation
  • Intervention/Treatment: Device: Active vacuum test prosthesis
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • 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
  • Official Title: Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Residual limb health at 16 weeks after use [ Time Frame: 16 Weeks ]
    Change from baseline in overall limb health in 16 wks
  • Secondary Outcome Measures: 1. Laser speckle flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
  • 2. TEWL measurement at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Transepidermal Water Loss (TEWL) value in 16 wks
  • 3. Hyperspectral Imaging at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Hyperspectral Imaging at 16 wks
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Jennifer Mohnacky, RDN (317)-278-2715 jmohnack@iu.edu

Contact: Tammy Garrett, RN (317) 278-2716 tjgarret@iupui.edu

Locations

United States, Indiana
IU Health Methodist Hospital
Indianapolis

Sponsors and Collaborators

Indiana University

United States Department of Defense

Investigators

Principal Investigator: Chandan Sen, PhD Indiana University

More Information