An interventional study of Pe-Lite and sleeve suspension socket and Total Surface bearing a socket with a sleeve suspension but without suction in Amputation, Diabetes Complications and Leg Injuries, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
218 studies on the registry are indexed under Diabetes Complications; 48 are open to participants now.
This study's enrollment of 7 is below the median of 70 across 133 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded if:
Comparison of five different clinically used suspension and socket systems
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)
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.
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.
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.
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.
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
Tissue oxygen saturation (StO2)
Time frame: Comparison of five different systems will be performed in one session occurring on one day
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development