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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Secondary outcome measures
Hyperspectral Imaging StO2% at 16wks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Laser Doppler flowmetry tissue perfusion values at 16wks
+4 more
Other outcome measures
Prosthesis evaluation questionnaire (PEQ)
Skin temperature values at 8wk

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
832 Previous Clinical Trials
505,895 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
2013. "Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01839123.
All > Health
~1 spots leftby May 2025
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