Trial · NCT02789033
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
NCT02789033, Phase 3, Completed, University of Guadalajara; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers. Trials, record NCT02789033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02789033
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
- NCT number
- NCT02789033
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- University of Guadalajara
- Conditions
- Diabetic Foot Ulcers
- Interventions
- Chitosan, Isosorbide dinitrate, Placebo
- First posted
- 2016-06-02
- Last updated
- 2021-01-12
- Results first posted
- 2021-01-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biopsies | 75 days | Histological changes in ulcers |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Biopsies | 75 days | UI/dL | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Biopsies | Active Comparator: Chitosan | α-smooth muscle actin | 2.46 | Standard Deviation 0.6 | UI/dL |
| Biopsies | Active Comparator: Isosorbide Dinitrate Spray | α-smooth muscle actin | 2.64 | Standard Deviation 0.6 | UI/dL |
| Biopsies | Combination: IDS and Chitosan | α-smooth muscle actin | 2.56 | Standard Deviation 0.6 | UI/dL |
| Biopsies | Placebo Comparator: Placebo | α-smooth muscle actin | 2.07 | Standard Deviation 0.6 | UI/dL |
| Biopsies | Active Comparator: Chitosan | Von Willebrand Factor | 2.38 | Standard Deviation 0.65 | UI/dL |
| Biopsies | Active Comparator: Isosorbide Dinitrate Spray | Von Willebrand Factor | 2.28 | Standard Deviation 0.82 | UI/dL |
| Biopsies | Combination: IDS and Chitosan | Von Willebrand Factor | 2.31 | Standard Deviation 0.8 | UI/dL |
| Biopsies | Placebo Comparator: Placebo | Von Willebrand Factor | 2.15 | Standard Deviation 0.5 | UI/dL |
| Biopsies | Active Comparator: Chitosan | vascular endothelial growth factor-A | 2.23 | Standard Deviation 0.8 | UI/dL |
| Biopsies | Active Comparator: Isosorbide Dinitrate Spray | vascular endothelial growth factor-A | 2.6 | Standard Deviation 0.6 | UI/dL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Comparator: Chitosan | 17 | |
| Overall Study | STARTED | Active Comparator: Isosorbide Dinitrate Spray | 17 | |
| Overall Study | STARTED | Combination: IDS and Chitosan | 17 | |
| Overall Study | STARTED | Placebo Comparator: Placebo | 17 | |
| Overall Study | COMPLETED | Active Comparator: Chitosan | 15 | |
| Overall Study | COMPLETED | Active Comparator: Isosorbide Dinitrate Spray | 15 | |
| Overall Study | COMPLETED | Combination: IDS and Chitosan | 16 | |
| Overall Study | COMPLETED | Placebo Comparator: Placebo | 15 | |
| Overall Study | NOT COMPLETED | Active Comparator: Chitosan | 2 | |
| Overall Study | NOT COMPLETED | Active Comparator: Isosorbide Dinitrate Spray | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Comparator: Chitosan | 0 | 17 |
| Total, all-cause mortality | Active Comparator: Isosorbide Dinitrate Spray | 0 | 17 |
| Total, all-cause mortality | Combination: IDS and Chitosan | 0 | 17 |
| Total, all-cause mortality | Placebo Comparator: Placebo | 0 | 17 |
| Total, other adverse events | Active Comparator: Chitosan | 0 | 17 |
| Total, other adverse events | Active Comparator: Isosorbide Dinitrate Spray | 0 | 17 |
| Total, other adverse events | Combination: IDS and Chitosan | 0 | 17 |
| Total, other adverse events | Placebo Comparator: Placebo | 0 | 17 |
| Total, serious adverse events | Active Comparator: Chitosan | 0 | 17 |
| Total, serious adverse events | Active Comparator: Isosorbide Dinitrate Spray | 0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02789033
GET https://conductscience.org/api/trials/v1/NCT02789033/registered