Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
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|ClinicalTrials.gov Identifier: NCT00985842|
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|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)||Not Applicable|
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 the investigators' photo-oximetry system, the investigators will measure and compare the tissue oxygenation along the medial and lateral surfaces (3 sites each) of the residual limb during rest and walking.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Socket System Effect on Tissue Oxygenation During Amputee Gait|
|Actual Study Start Date :||November 1, 2009|
|Actual Primary Completion Date :||October 26, 2012|
|Actual Study Completion Date :||October 26, 2012|
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.
- Oxygen in tissue [ Time Frame: Comparison of five different systems will be performed in one session occurring on one day ]Tissue oxygen saturation (StO2)
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): NCT00985842
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Glenn K Klute, PhD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|