Status:
TERMINATED
Topical Oxygen Therapy for Diabetic Wounds
Lead Sponsor:
Indiana University
Conditions:
Diabetic Foot Ulcers
Wound
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial. Eleven subjects were enrolled at The Ohio State University; we inte...
Detailed Description
There are a total of 5 study visits including the initial baseline visit were they will be randomized into one of the 2 groups (comparison or treatment). At the baseline visit the following will be co...
Eligibility Criteria
Inclusion
- Age \>18 years
- Able to give informed consent, willing and able to visit the hospital and CWC for regular treatment and follow-up visits.
- Diabetic
- -Chronic wound OR Foot Ulcer:
- Ulcer present by history ≥ 4 weeks at time of enrollment
- Compliant with standard wound care regimen
- IF foot wound, Wagner grade 1 and 2, OR Wagner grade 3
- Ulcer size: 0.6 cm2 to 20 cm2 and has not decreased in size by more than 30% in previous 2 weeks of the enrollment visit
- Adequate circulatory status, as evidenced by any of the following:
- Ankle Brachial Index (ABI) ≥0.7 - ≥ 1.20
- If ABI non-compressible (ABI \>1.2), then toe brachial Index (TBI)\>0.5
- SPP \> 30mmHg
- TcOM \> 30mmHg
- At least 4 weeks since revascularization procedure, if one has been performed
- Able to complete Topical Oxygen Therapy 4 day/week for 16 weeks (must be able to remove existing wound dressing and apply TO2 Boot/treatment, and then re-dress wound)
Exclusion
- Ulcer in area of radiation treatment.
- Active malignancy at site of ulcer
- Current treatment with wound VAC or weekly compression dressing
- Untreated infection at site of ulcer (i.e. cellulitis or osteomyelitis)
- If acute osteomyelitis has been diagnosed, patient may be enrolled only after the infection has been controlled. Including:
- Debridement of infected bone if necessary
- Patient has received at least 2 weeks of appropriate antibiotics
- ABI \< 0.7 or \> 1.2
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02313428
Start Date
February 1 2020
End Date
August 5 2021
Last Update
April 25 2024
Active Locations (1)
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1
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202