Evaluation of a Novel Transfemoral Prosthetic Socket System

Ohio Willow Wood8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lower Limb Amputation

Interventions

Conventional Prosthetic Transfemoral Socket SystemDEVICE

Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket

Novel Prosthetic transfemoral socket systemDEVICE

Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Smoker

Locations (2)

The Ohio State University Davis Heart and Lung Research Institute

Columbus, Ohio, United States

RECRUITING

The Ohio Willow Wood Company

Mount Sterling, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Laser Doppler flowmetry tissue perfusion values

Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month

Time frame: 1 month

Secondary Outcomes

Laser speckle flowmetry tissue perfusion values

Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month

Time frame: 1 month

Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)

Change from baseline in hyperspectral imaging StO2% at 1 month

Time frame: 1 month

Trans-Epidermal Water Loss values

Change from baseline in trans-epidermal water loss values at 1 month

Time frame: 1 month

Surface electrical capacitance values

Change from baseline in surface electrical capacitance values at 1 month

Time frame: 1 month

Elasticity (cutometry) values

Change from baseline in elasticity values at 1 month

Time frame: 1 month

Torsional Ballistometry values

Change from baseline in torsional ballistometry values at 1 month

Time frame: 1 month

Central Contacts

Ryan Schroeder

CONTACT

740-869-3377 ryans@owwco.com

Data from ClinicalTrials.gov

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