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Transdermal Continuous Oxygen Therapy for Lower Limb

N/A
Waitlist Available
Led By Khanjan Nagarsheth, MD
Research Sponsored by Neogenix, LLC dba Ogenix
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 90 days
Awards & highlights

Study Summary

This study is evaluating whether a new method of delivering oxygen to wounds may help reduce infection rates and speed up healing.

Eligible Conditions
  • Revascularization
  • Incision
  • Surgical Wound Healing
  • Lower Limb

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool
Secondary outcome measures
Incidence of surgical site infection as determined by Szilagyi Tool

Trial Design

2Treatment groups
Active Control
Group I: Transdermal Continuous Oxygen TherapyActive Control1 Intervention
Subjects who satisfy the inclusion/exclusion conditions will be randomly assigned to the Treatment arm which provides Transdermal Continuous Oxygen Treatment (TCOT) (as delivered by EPIFLO device), in addition to standard of care for the surgical wound
Group II: ControlActive Control1 Intervention
Subjects who satisfy the inclusion/exclusion conditions will be randomly assigned to the control arm which provides standard of care for the surgical wound.

Find a Location

Who is running the clinical trial?

Neogenix, LLC dba OgenixLead Sponsor
4 Previous Clinical Trials
130 Total Patients Enrolled
University of Maryland, College ParkOTHER
155 Previous Clinical Trials
45,565 Total Patients Enrolled
Khanjan Nagarsheth, MDPrincipal InvestigatorUniversity of Maryland, School of Medicine, Baltimore MD

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
Oxygen for Vascular Incisional Healing
2019. "Oxygen for Vascular Incisional Healing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03746132.
~16 spots leftby Apr 2025
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