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Hyperbaric Oxygen Therapy for Amputation Recovery

Phase 1 & 2
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to receive hyperbaric oxygen therapy
Non-traumatic indication for lower limb amputation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after amputation
Awards & highlights

Study Summary

This trial is testing whether adding hyperbaric oxygen to standard care can reduce complications after an amputation below the knee. The goal is to compare complication rates, hospital stays, and mortality rates between treatment and standard care groups.

Who is the study for?
This trial is for individuals who are undergoing below-the-knee amputations and can receive hyperbaric oxygen therapy. They must be able to consent to the treatment. People with limb loss due to trauma, second amputation, pregnancy, certain systemic diseases like end-stage renal disease or cancer under active treatment are excluded.Check my eligibility
What is being tested?
The study tests if using hyperbaric oxygen (HBO2) right after surgery can lower complications in patients having below-the-knee amputations. Participants will be randomly placed into two groups: one receiving HBO2 along with standard care and another receiving only standard care, to compare outcomes.See study design
What are the potential side effects?
Hyperbaric oxygen therapy may cause ear pain or damage due to increased pressure, temporary nearsightedness, lung collapse caused by air pressure changes (rare), and seizures due to too much oxygen (also rare).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can undergo hyperbaric oxygen therapy.
Select...
My leg amputation is not due to an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during inpatient stay immediately after amputation
This trial's timeline: 3 weeks for screening, Varies for treatment, and during inpatient stay immediately after amputation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inpatient death
Re-operation
Wound infection
Secondary outcome measures
90-day mortality
Ambulate with prosthesis
Complete healing of amputation wound healing at 4 weeks following surgery
+2 more
Other outcome measures
Hospital readmission

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hyperbaric Oxygen Plus Regular CareExperimental Treatment1 Intervention
Hyperbaric oxygen (2 hours at 2 atmospheres absolute) to be administered 1-2 times daily for up to 10 treatments after amputation. Usual care for patients with amputation will be administered in parallel.
Group II: Regular CareActive Control1 Intervention
Usual care for patients with amputation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen
2005
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,418,985 Total Patients Enrolled

Media Library

Hyperbaric Oxygen Clinical Trial Eligibility Overview. Trial Name: NCT04717557 — Phase 1 & 2
Amputation Research Study Groups: Hyperbaric Oxygen Plus Regular Care, Regular Care
Amputation Clinical Trial 2023: Hyperbaric Oxygen Highlights & Side Effects. Trial Name: NCT04717557 — Phase 1 & 2
Hyperbaric Oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04717557 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are being helped by this clinical trial?

"Yes, according to the latest update on clinicaltrials.gov, this research is looking for new participants. The trial was first posted on 1/1/2021 and was last updated on 2/15/2022. The goal is to have 140 people enrolled at 1 site."

Answered by AI

Are people with the required medical conditions currently being signed up for this research project?

"That is correct. The listing on clinicaltrials.gov states that this trial is currently looking for participants. The listing was first posted on January 1st, 2021 and updated on February 15th, 2022. They are hoping to enroll 140 patients at a single site."

Answered by AI
~27 spots leftby Dec 2024