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

NCT03927404 | Completed Results DMC FDA Device

• 2 other identifiers: 1809327674W81XWH-16-2-0059
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation

Keywords

Transfemoral Amputees; Transtibial Amputees; Prosthesis

Outcome Measures

Primary Outcomes (1)

• Ratio of Trans-epidermal Water Loss (TEWL) at 16 Weeks After Use

  Trans-epidermal Water Loss in 16 wks. Higher TEWL value represents a worse outcome with loss of skin barrier function. The value reported is the ratio of the TEWL of residual limb over TEWL value of the sound side limb.

  Baseline and 16 Weeks

Secondary Outcomes (2)

• Change in Hyperspectral Imaging at 16 Wks

  Baseline to16 weeks

• Ultrasound Measurements at 16 Wks

  16 weeks

Study Arms (1)

Adaptive Vacuum test Prosthesis

EXPERIMENTAL

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

Interventions

Active vacuum test prosthesis DEVICE

The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic 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.

Also known as: Limb logic system

Adaptive Vacuum test Prosthesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or through Legally Authorized Representative.
• Must be able to ambulate without assistance. An external assistance device such as cane or walker will be permitted.
• Adequate arterial blood flow as evidenced by a TcOM \>30mmHg measured within the past 12 months.

You may not qualify if:

• Conditions that prevent wearing a prosthetic socket,such as existing scab, ulcer, or keloid scar on amputation stump.
• 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

Sponsors & Collaborators

• Indiana University: lead
• United States Department of Defense: collaborator

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (9)

• Epstein RA, Heinemann AW, McFarland LV. Quality of life for veterans and servicemembers with major traumatic limb loss from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010;47(4):373-85. doi: 10.1682/jrrd.2009.03.0023.

  PMID: 20803405 BACKGROUND

• Schultz AE, Baade SP, Kuiken TA. Expert opinions on success factors for upper-limb prostheses. J Rehabil Res Dev. 2007;44(4):483-9. doi: 10.1682/jrrd.2006.08.0087.

  PMID: 18247245 BACKGROUND

• Zachariah SG, Saxena R, Fergason JR, Sanders JE. Shape and volume change in the transtibial residuum over the short term: preliminary investigation of six subjects. J Rehabil Res Dev. 2004 Sep;41(5):683-94. doi: 10.1682/jrrd.2003.10.0153.

  PMID: 15558398 BACKGROUND

• Fernie GR, Holliday PJ. Volume fluctuations in the residual limbs of lower limb amputees. Arch Phys Med Rehabil. 1982 Apr;63(4):162-5.

  PMID: 7082139 BACKGROUND

• Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189.

  PMID: 22068373 BACKGROUND

• Krueger CA, Wenke JC, Ficke JR. Ten years at war: comprehensive analysis of amputation trends. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S438-44. doi: 10.1097/TA.0b013e318275469c.

  PMID: 23192067 BACKGROUND

• Ramasamy A, Hill AM, Phillip R, Gibb I, Bull AM, Clasper JC. The modern "deck-slap" injury--calcaneal blast fractures from vehicle explosions. J Trauma. 2011 Dec;71(6):1694-8. doi: 10.1097/TA.0b013e318227a999.

  PMID: 21808204 BACKGROUND

• Bui KM, Raugi GJ, Nguyen VQ, Reiber GE. Skin problems in individuals with lower-limb loss: literature review and proposed classification system. J Rehabil Res Dev. 2009;46(9):1085-90. doi: 10.1682/jrrd.2009.04.0052.

  PMID: 20437314 BACKGROUND

• Harris AM, Althausen PL, Kellam J, Bosse MJ, Castillo R; Lower Extremity Assessment Project (LEAP) Study Group. Complications following limb-threatening lower extremity trauma. J Orthop Trauma. 2009 Jan;23(1):1-6. doi: 10.1097/BOT.0b013e31818e43dd.

  PMID: 19104297 BACKGROUND

Results Point of Contact

• Title: Dr. Sashwati Roy
• Organization: University of Pittsburgh

sar453@pitt.edu

412-648-8297

Study Officials

• Chandan Sen, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice President of Research

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: February 12, 2020
• Primary Completion: August 25, 2021
• Study Completion: September 6, 2021
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-05

Locations

US (1)