Prosthetic Socket System: Pilot Assessment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation
- Sponsor
- Ohio Willow Wood
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Laser Doppler flowmetry tissue perfusion values
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.
Detailed Description
Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consenting Adult
- •Unilateral transfemoral amputee
- •Currently suing a liner with prosthesis
- •Uses a prosthesis to ambulate
- •Ability to read, write, and understand English
- •Available during regular business hours for appointments
Exclusion Criteria
- •Impaired contra lateral leg
- •Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
- •Diagnosis of renal failure
Outcomes
Primary Outcomes
Laser Doppler flowmetry tissue perfusion values
Time Frame: 1 month
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month
Secondary Outcomes
- Laser speckle flowmetry tissue perfusion values(1 month)
- Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)(1 month)
- Trans-Epidermal Water Loss values(1 month)
- Surface electrical capacitance values(1 month)
- Elasticity (cutometry) values(1 month)
- Torsional Ballistometry values(1 month)