Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT02313428
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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:
1. Debridement of infected bone if necessary
2. Patient has received at least 2 weeks of appropriate antibiotics
* ABI \< 0.7 or \> 1.2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02313428
Study Brief:
Protocol Section:
NCT02313428