Trial · NCT02418676
Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Use of the Complex in Gel for Healing of Pressure Ulcers
NCT02418676, Phase 1, Phase 2, Completed, State University of Maringá; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Use of the Complex in Gel for Healing of Pressure Ulcers. Trials, record NCT02418676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02418676
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Use of the Complex in Gel for Healing of Pressure Ulcers
- NCT number
- NCT02418676
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- State University of Maringá
- Conditions
- Pressure Ulcer, Wound
- Interventions
- Gel with HPβCD-I complex, Gel with insulin, Control gel
- First posted
- 2015-04-16
- Last updated
- 2016-01-14
- Results first posted
- 2016-01-14
- Limitations and caveats
- Small numbers of subjects analyzed because of the type of pressure ulcer selected.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Index (%EI) | Measured every 3 days for 15 days | Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value. |
| Secondary | Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients | Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days | Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Index (%EI) | Measured every 3 days for 15 days | Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing. | percentage (%) | MEAN |
| SECONDARY | Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients | Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days | Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Index (%EI) | Gel With HPβCD-I Complex | 82.76 | 95% Confidence Interval 78.25 to 86.15 | percentage (%) | |
| Efficacy Index (%EI) | Gel With Insulin | 43.66 | 95% Confidence Interval 39.73 to 47.03 | percentage (%) | |
| Efficacy Index (%EI) | Control Gel | 14.58 | 95% Confidence Interval 12.53 to 16.25 | percentage (%) | |
Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients | Gel With HPβCD-I Complex | 167.20 | 95% Confidence Interval 153.92 to 208.90 | mg/dL | |
Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients | Gel With Insulin | 168.88 | 95% Confidence Interval 155.12 to 209.39 | mg/dL | |
Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients | Control Gel | 196.07 | 95% Confidence Interval 103.00 to 325.00 | mg/dL |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gel With HPβCD-I Complex | 5 | |
| Overall Study | STARTED | Gel With Insulin | 5 | |
| Overall Study | STARTED | Control Gel | 5 | |
| Overall Study | COMPLETED | Gel With HPβCD-I Complex | 5 | |
| Overall Study | COMPLETED | Gel With Insulin | 5 | |
| Overall Study | COMPLETED | Control Gel | 5 | |
| Overall Study | NOT COMPLETED | Gel With HPβCD-I Complex | 0 | |
| Overall Study | NOT COMPLETED | Gel With Insulin | 0 | |
| Overall Study | NOT COMPLETED | Control Gel | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gel With HPβCD-I Complex | ||
| Total, all-cause mortality | Gel With Insulin | ||
| Total, all-cause mortality | Control Gel | ||
| Total, other adverse events | Gel With HPβCD-I Complex | 0 | 5 |
| Total, other adverse events | Gel With Insulin | 0 | 5 |
| Total, other adverse events | Control Gel | 0 | 5 |
| Total, serious adverse events | Gel With HPβCD-I Complex | 0 | 5 |
| Total, serious adverse events | Gel With Insulin | 0 | 5 |
| Total, serious adverse events | Control Gel | 0 | 5 |
Source ClinicalTrials.gov
Papers3
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/NCT02418676
GET https://conductscience.org/api/trials/v1/NCT02418676/registered