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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

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.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Device: Active vacuum test prosthesis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Hyperspectral Imaging at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in Hyperspectral Imaging at 16 wks

  3. Laser speckle flowmetry tissue perfusion values at 16wks [ Time Frame: 16 weeks ]
    Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks

  4. TEWL measurement at 16 wks [ Time Frame: 16 weeks ]
    Change from baseline in TEWL value in 16 wks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927404


Contacts
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Contact: Jennifer Mohnacky, RDN (317)-278-2715 jmohnack@iu.edu
Contact: Tammy Garrett, RN (317) 278-0290 tjgarret@iupui.edu

Locations
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United States, Indiana
IU Health Methodist Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mohnacky Jennifer, RDN    317-278-2715    jmohnack@iu.edu   
Contact: Tammy Garrett, RN    (317) 278-0290    tjgarret@iupui.edu   
Sub-Investigator: Sashwati Roy, PhD         
Sub-Investigator: Gayle Gordillo, MD         
Sponsors and Collaborators
Indiana University
United States Department of Defense
Investigators
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Principal Investigator: Chandan Sen, PhD Indiana University

Publications:

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Responsible Party: Chandan Sen, Associate Vice President of Research, Indiana University
ClinicalTrials.gov Identifier: NCT03927404     History of Changes
Other Study ID Numbers: 1809327674
OR150169 ( Other Grant/Funding Number: DoD )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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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
Keywords provided by Chandan Sen, Indiana University:
Transfemoral Amputees
Transtibial Amputees
Prosthesis