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

Not Applicable

Completed

• Conditions: Diabetes Complications; Traumatic Amputation; Amputation; Leg Injuries
• Interventions: 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)

• Registration Number: NCT00985842
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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 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 Timeline

• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-29
• Study Start: 2009-11-01
• Primary Completion: 2012-10-26
• Study Completion: 2012-10-26
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Pe-Lite and sleeve suspension socket	Comparison of five different clinically used suspension and socket systems
Arm 1	Total surface bearing suction socket with a pin lock suspension	Comparison of five different clinically used suspension and socket systems
Arm 1	Total Surface bearing a socket with a sleeve suspension but without suction	Comparison of five different clinically used suspension and socket systems
Arm 1	Total surface bearing suction socket with a sleeve suspension	Comparison of five different clinically used suspension and socket systems
Arm 1	Vacuum-assisted socket system (Harmony System, Otto Bock)	Comparison of five different clinically used suspension and socket systems

Primary Outcome Measures

Name	Time	Method
Oxygen in tissue	Comparison of five different systems will be performed in one session occurring on one day	Tissue oxygen saturation (StO2)

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States