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Prosthetic Socket System

Vacuum Socket for Lower Limb Amputation

N/A
Waitlist Available
Led By Gayle Gordillo, MD
Research Sponsored by Ohio Willow Wood
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Secondary study objectives
Hyperspectral Imaging StO2% at 16wks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Laser Doppler flowmetry tissue perfusion values at 16wks
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vacuum SocketExperimental Treatment1 Intervention
Prosthetic LimbLogic vacuum socket
Group II: Non-Vacuum SocketActive Control1 Intervention
Prosthetic suction or pin socket

Find a Location

Who is running the clinical trial?

Ohio Willow WoodLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
8 Patients Enrolled for Lower Limb Amputation
Ohio State UniversityOTHER
866 Previous Clinical Trials
655,147 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
8 Patients Enrolled for Lower Limb Amputation
Gayle Gordillo, MDPrincipal InvestigatorOhio State University
6 Previous Clinical Trials
189 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
8 Patients Enrolled for Lower Limb Amputation
~1 spots leftby Nov 2025
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