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Prosthetic Socket System

Novel TF Socket System 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 1 month
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Laser Doppler flowmetry tissue perfusion values
Secondary outcome measures
Elasticity (cutometry) values
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)
Laser speckle flowmetry tissue perfusion values
+3 more
Other outcome measures
Prosthesis evaluation questionnaire (PEQ)
Skin temperature values

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Novel TF Socket SystemExperimental Treatment1 Intervention
Novel Prosthetic Transfemoral Socket System
Group II: Conventional TF Socket SystemActive Control1 Intervention
Conventional Prosthetic Transfemoral Socket System

Find a Location

Who is running the clinical trial?

Ohio Willow WoodLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
10 Patients Enrolled for Lower Limb Amputation
Ohio State UniversityOTHER
859 Previous Clinical Trials
642,757 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
10 Patients Enrolled for Lower Limb Amputation
Gayle Gordillo, MDPrincipal InvestigatorOhio State University
6 Previous Clinical Trials
191 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
10 Patients Enrolled for Lower Limb Amputation
~1 spots leftby Sep 2025
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