Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00985842
First received: December 11, 2007
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.


Condition Intervention
Amputation
Diabetes Complications
Leg Injuries
Traumatic Amputation
Device: Pe-Lite and sleeve suspension socket
Device: Total Surface bearing a socket with a sleeve suspension but without suction
Device: Total surface bearing suction socket with a pin lock suspension
Device: Total surface bearing suction socket with a sleeve suspension
Device: Vacuum-assisted socket system (Harmony System, Otto Bock)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Socket System Effect on Tissue Oxygenation During Amputee Gait

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Oxygen in tissue [ Time Frame: Comparison of five different systems will be performed in one session occurring on one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Comparison of five different clinically used suspension and socket systems
Device: Pe-Lite and sleeve suspension socket
Prosthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket.
Device: Total Surface bearing a socket with a sleeve suspension but without suction
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket.
Device: Total surface bearing suction socket with a pin lock suspension
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee.
Device: Total surface bearing suction socket with a sleeve suspension
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension.
Device: Vacuum-assisted socket system (Harmony System, Otto Bock)
Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb.

Detailed Description:

The amount of oxygen in residual limb tissue is an important health status indicator; resistance to infection, promotion of wound healing, production of collagen, and epithelialization all correlate with higher oxygen levels. Unfortunately, simply donning a lower limb prosthesis may limit circulation and reduce the level of tissue oxygenation. This reduction may be compounded by the biomechanical forces of gait. The compressive loads of the body's weight during stance and the inertial loads of the prosthesis during swing may further occlude circulation, albeit by different mechanisms.

For the dysvascular lower limb amputee, the choice of prosthetic socket and suspension system may impact the overall health of their residual limb and wound healing capacity. An inappropriate choice may lead to skin irritation, tissue breakdown, discomfort, and reduced mobility. For these patients, any component that reduces tissue oxygenation is a significant problem because compromised circulation can forestall wound healing.

The objective of the proposed research is to use photo-oximetry to discover which of five different prosthetic limb systems results in higher residual limb tissue oxygenation during both rest and gait. This experiment will enable evidence-based decision making on this clinically relevant problem. Using a prospective, randomized cross-over experimental design and our photo-oximetry system, we will measure and compare the tissue oxygenation along the medial and lateral surfaces (3 sites each) of the residual limb during rest and walking.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All subjects must meet the following inclusion criteria:

  • unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70,
  • have been fit with a prosthesis and have used a prosthesis for at least one year,
  • wear the prosthesis at least 4 hours per day,
  • ambulate without upper extremity aids, and
  • have no history of injurious falls within the previous six months.

Exclusion Criteria:

Subjects will be excluded if:

  • they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or
  • their residual limb is ulcerated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985842

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00985842     History of Changes
Other Study ID Numbers: A4378-R
Study First Received: December 11, 2007
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Artificial limbs
Gait
Oximetry
Prosthesis
Rehabilitation

Additional relevant MeSH terms:
Amputation, Traumatic
Diabetes Complications
Leg Injuries
Diabetes Mellitus
Endocrine System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014