At a glance
ClinicalIndex Comparison Record- ✓Age 18 to <70 years
- ✓Below-knee amputation, one side only
- ✓For traumatic amputation without diabetes/vascular disease: ≥6 months post-amputation and ≥4 months prosthesis use
- ✓For diabetes/vascular amputation: ≥1 year prosthesis use
- ✕Pain in legs or any condition that interferes with walking
- ✕Ulcer on residual limb
- ✕Active tumor or ongoing tumor treatment (if amputation was due to tumor or infection)
- ✕Fall within last 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
In Brief
A clinical study evaluating Total Surface Bearing Suction Socket and Vacuum assisted socket system for Amputation and 3 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system. The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.
Study Details
Timeline
Interventions
Current clinical practice
Novel socket system