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Device

combined use of vacuum assisted suction and heat exchanger warming for Digital Ischemia (DIR Trial)

N/A
Waitlist Available
Led By Bartlomiej Imielski, MD
Research Sponsored by Wake Forest University Health Sciences
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 day 14
Awards & highlights
No Placebo-Only Group

Summary

This trial will study a device to reduce pressor reliance in high-dose-dependent patients.

Eligible Conditions
  • Digital Ischemia
  • Cardiogenic Shock
  • Hypovolemic Shock

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of digital ischemia
Secondary study objectives
extent of digital ischemia - length of digits involved
extent of digital ischemia - number of digits involved

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: combined use of vacuum assisted suction and heat exchanger warmingExperimental Treatment1 Intervention
The novel idea that this study proposes, is the combined use of vacuum assisted suction and heat exchanger warming. It is well known that heat causes capillary vasodilation, where warming hands and toes improves blood flow while cooling them causes vasoconstriction. Applying a vacuum across a capillary bed increases the transcapillary gradient increasing the driving force of blood flow into tissues. The combination of these two mechanisms can work synchronously to improve blood flow to ischemic extremities and digits.
Group II: expectant medical managementActive Control1 Intervention
expectant medical management will continue to the contralateral hand

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,341 Previous Clinical Trials
1,029,680 Total Patients Enrolled
Bartlomiej Imielski, MDPrincipal InvestigatorWake Forest University Health Sciences
~0 spots leftby Nov 2024
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