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NCT02501538 · ClinicalTrials.gov registry record · NA
Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT02501538 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants.
The verdict
NCT02501538, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the Transcutaneous O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, and vascular evaluations (Transcutaneous oxygen measurements and Hyperspectral imaging. will be performed at each study visit(research). Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.
Interventions
- DEVICE Transcutaneous O2 device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-06 |
| Est. Completion | 2020-01-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02501538
The ClinicalTrials.gov registry entry for NCT02501538 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous O2 device is the first listed.
NCT02501538 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02501538 about?
NCT02501538 is a clinical study titled "Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers". This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard ...
What is the current status of trial NCT02501538?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2015-06. Estimated completion is 2020-01-10.
What interventions are being tested in trial NCT02501538?
The interventions under investigation include: Transcutaneous O2 device (DEVICE).
Who is sponsoring clinical trial NCT02501538?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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