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Topical Oxygen Therapy for Diabetic Foot Ulcers
N/A
Waitlist Available
Led By Chandan K. Sen, PhD
Research Sponsored by Indiana University
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
This trial is testing if a new medical intervention is effective and if it is worth doing a larger trial.
Who is the study for?
This trial is for adults over 18 with diabetes and chronic foot ulcers that have been present for at least 4 weeks. Participants must be able to attend regular treatment sessions, manage their wound care, and commit to a 16-week topical oxygen therapy regimen four days a week. They should not have an ulcer from radiation or active cancer at the site, untreated infections, or certain circulation problems.Check my eligibility
What is being tested?
The study tests Topical Oxygen Chamber therapy on diabetic wounds to see if it's feasible and cost-effective. It will also look into health improvements in patients. This small pilot study aims to gather data for planning a larger trial by enrolling additional participants at Indiana University.See study design
What are the potential side effects?
Since this is a feasibility study primarily focused on gathering data about the use of Topical Oxygen Therapy (TO2), specific side effects are not detailed here. However, typical concerns might include skin irritation around the wound or discomfort associated with the therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound Closure
Secondary outcome measures
Complication Rate
Cost of Care
Quality of Life for subjects- SF-36
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care with Topical Oxygen TreatmentExperimental Treatment1 Intervention
patients who have a chronic wound, will receive their receive standard treatment plus Topical Oxygen Therapy (Topical Oxygen Chamber for Extremities).
Group II: Standard of Care onlyActive Control1 Intervention
patients that have a chronic wound will receive only their standard of care treatment.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,121 Total Patients Enrolled
7 Trials studying Foot Ulcer
1,619 Patients Enrolled for Foot Ulcer
Chandan K. Sen, PhDPrincipal InvestigatorIndiana University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are older than 18 years.If you have a foot wound that is either Wagner grade 1 or 2, or Wagner grade 3.You have an ulcer in the area where you received radiation treatment.You currently have an active cancer at the site of the ulcer.You are currently receiving treatment with a wound VAC or weekly compression dressing.You have an infection in the area of the ulcer that has not been treated yet.Your ankle-brachial index (ABI) is too low or too high.You have diabetes.You have had a wound or foot ulcer for at least 4 weeks before joining the study.Your ulcer is between 0.6 square centimeters and 20 square centimeters, and it hasn't gotten smaller by more than 30% in the last two weeks.Your blood circulation is good, as shown by specific tests for blood flow in your legs.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care only
- Group 2: Standard of Care with Topical Oxygen Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spots remaining in this trial for prospective participants?
"According to the clinicaltrials.gov website, this research study is actively searching for participants as of now. This trial was uploaded on February 1st 2020 with its latest update being recorded on February 22nd 2022."
Answered by AI
What is the aggregate enlistment rate of participants in this trial?
"Affirmative. Clinicaltrials.gov indicates that this study is still recruiting patients; it was published on February 1st 2020 and its information was last updated on February 22nd 2022, with the aim of enrolling 40 individuals at a single medical centre."
Answered by AI
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