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Topical Oxygen Therapy for Diabetic Wounds
NA trial testing Topical Oxygen Chamber for Extremities in Diabetic Foot Ulcers in 4 participants. Terminated before completion.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 1 February 2020 |
| Primary completion | 5 August 2021 |
| Estimated completion | 5 August 2021 |
| Sites | 1 location across United States |
Indiana University
18 and older, any sex, with Diabetic Foot Ulcers or Wound. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Wound healing rates at 16 weeks of Topical Oxygen Therapy or Standard of Care
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | 3.3 | 3.3 – 3.3 |
| Standard of Care Only | 0.00 | 0.00 – 0.00 |
Amputations rates 16 weeks of Topical Oxygen Therapy or Standard of Care
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | 0 | |
| Standard of Care Only | 0 |
Complication rates (infection) at 16 weeks of Topical Oxygen Therapy or Standard of Care
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | 1 | |
| Standard of Care Only | 1 |
QoL data at 16 weeks of Topical Oxygen Therapy or Standard of Care. A cumulative score was calculated based on the QoL responses: Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care With Topical Oxygen Treatment | 38.9 | |
| Standard of Care Only | 51.5 |
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 intend to enroll 29 more subjects at Indiana University. Due to the small sample size this study will primarily be a feasibility study that will attempt to measure and evaluate differences in the relative theoretical costs of the intervention of topical oxygen therapy on this population and subsequently compare outcomes in areas such as overall health improvements and cost effectiveness.
No peer-reviewed publications indexed yet for this trial.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02313428.
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