Trial · NCT02871011
Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
NCT02871011, Phase 2, Completed, Nitric Solutions Inc.; results first posted 2019-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot. Trials, record NCT02871011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02871011
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
- NCT number
- NCT02871011
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Nitric Solutions Inc.
- Conditions
- Tinea Pedis
- Interventions
- Nitric Oxide, Water
- First posted
- 2016-08-18
- Last updated
- 2019-09-20
- Results first posted
- 2019-09-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Cure: Post Treatment (Day 17) | Day 17 | Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. |
| Primary | Number of Participants With Complete Cure: Post Treatment (Day 31) | Day 31 | Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score. |
| Primary | Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Day 17 | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score. |
| Primary | Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Day 31 | Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score. |
| Primary | Incidence of Adverse Events | Duration of the study, 31 days for each participant. | Number of moderate A/E possibly related to treatment |
| Secondary | Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | Day 1 and 31 | Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of \>20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Cure: Post Treatment (Day 17) | Day 17 | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Complete Cure: Post Treatment (Day 31) | Day 31 | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Day 17 | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Day 31 | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Adverse Events | Duration of the study, 31 days for each participant. | Intent to treat enrollment was 20 individuals. | Events | NUMBER |
| SECONDARY | Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | Day 1 and 31 | Intent to treat enrollment was 20 individuals. | Clinial symptom Severity Score | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Cure: Post Treatment (Day 17) | Control | 0 | Participants | ||
| Number of Participants With Complete Cure: Post Treatment (Day 17) | Nitric Oxide | 4 | Participants | ||
| Number of Participants With Complete Cure: Post Treatment (Day 31) | Control | 0 | Participants | ||
| Number of Participants With Complete Cure: Post Treatment (Day 31) | Nitric Oxide | 5 | Participants | ||
| Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Control | 2 | Participants | ||
| Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Nitric Oxide | 0 | Participants | ||
| Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Control | 1 | Participants | ||
| Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Nitric Oxide | 0 | Participants | ||
| Incidence of Adverse Events | Control | 0 | Events | ||
| Incidence of Adverse Events | Nitric Oxide | 3 | Events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 7 | |
| Overall Study | STARTED | Nitric Oxide | 13 | |
| Overall Study | COMPLETED | Control | 7 | |
| Overall Study | COMPLETED | Nitric Oxide | 13 | |
| Overall Study | NOT COMPLETED | Control | 0 | |
| Overall Study | NOT COMPLETED | Nitric Oxide | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Discomfort -warm/sting | Skin and subcutaneous tissue disorders | Control | 0 | 7 | 0 |
| other | Discomfort -warm/sting | Skin and subcutaneous tissue disorders | Nitric Oxide | 3 | 13 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | 0 | 7 |
| Total, all-cause mortality | Nitric Oxide | 0 | 13 |
| Total, other adverse events | Control | 0 | 7 |
| Total, other adverse events | Nitric Oxide | 3 | 13 |
| Total, serious adverse events | Control | 0 | 7 |
| Total, serious adverse events | Nitric Oxide | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nitric Oxide vs Control: Number of Participants With Complete Cure: Post Treatment (Day 31) | Trial comparisons |
| Nitric Oxide vs Control: Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | Trial comparisons |
| Nitric Oxide vs Control: Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | Trial comparisons |
| Nitric Oxide vs Control: deaths from any cause | Trial comparisons |
| Nitric Oxide vs Control: Number of Participants With Complete Cure: Post Treatment (Day 17) | Trial comparisons |
| Nitric Oxide vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02871011
GET https://conductscience.org/api/trials/v1/NCT02871011/registered