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

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ClinicalTrials.gov Identifier: NCT03927404
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : August 5, 2019
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 August 5, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03927404 on ClinicalTrials.gov Archive Site
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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
  • No Intervention: Standard of care prosthesis
    Control standard of care arm where the subject continues to use their standard of care socket and prosthesis device such as pin-lock or suction sockets
  • 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Ages of 18 and above
  • 2. Unilateral transtibial or transfemoral amputee
  • 3. Ambulate at a K2 level or higher
  • 4.At least 3 months post-amputation per physician discretion
  • 5.Residual limb length greater than 6.5 inches in length
  • 6.Able to follow directions and give informed consent on their own
  • 7.Must be able to ambulate without assistance

Exclusion Criteria:

  • 1. Conditions that prevent wearing a prosthetic socket
  • 2. Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
  • 3.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) 278-0290 tjgarret@iupui.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927404
Other Study ID Numbers  ICMJE 1809327674
OR150169 ( 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
Device Product Not Approved or Cleared by U.S. FDA: No
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 August 2019

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