- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418676
Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Use of the Complex in Gel for Healing of Pressure Ulcers
Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Spectroscopic Evaluation of Molecular Inclusion and Use of the Complex in Gel for Healing of Pressure Ulcers
The coprecipitation method was used to prepare hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) by mixing insulin with hydroxypropyl-beta-cyclodextrin (HPβCD) in the molar ratio of 1:5 with the addition of 10 mL of purified water for every 100 mg of the complex. After complete dissolution of the material, the mixture was stirred for 30 min at room temperature (25°C), then left to rest for 60 min and lyophilized.
The gel was prepared by dispersing the Carbopol 940® polymer in a known amount of purified water. Under mild heating the methylparaben (0.02%, w/v), propylparaben (0.01%, w/v) and propylene glycol were dissolved and incorporated in the dispersion of Carbopol 940® and left to rest for a period of 12h. After this time, the prepared gel was stirred and pH corrected to a range of 5.0 to 7.0 with triethanolamine. A set amount of insulin and the HPβCD-I complex were incorporated into the control gel for the preparation of other formulations.
A randomized, double-blind, prospective clinical trial was conducted from March 2013 to April 2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order to determine the safety and efficacy of gel in patients hospitalized in the Intensive Care Unit.
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.
A letter of free and informed consent was obtained. The study was conducted with each patient for a period of 15 days.
The volunteers were divided equally into three groups A, B and C, with each group being formed by five volunteers (n=5). Group A was randomly selected for treatment with gel with HPβCD-I complex, group B for treatment with gel with insulin, and group C with the control gel.
Blood glucose tests were performed in order to assess whether the insulin complexed or otherwise with HPβCD could cause an increase in the rate of insulin in the blood in patients, leading to hypoglycemia.
An identical standardized procedure for gel placement was used for all patients. Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers 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).
Data was evaluated by variance analysis (ANOVA), and means were compared with the Tukey test (p < 0.05) using the software Statistica 8.0/2008 (Stat Soft Inc., Tulsa, USA).
Mixed model repeated measures methodology with some covariance structures was adopted for statistical analysis of the clinical trial (p < 0.05). The Statistical Analysis System (SAS) for Windows, version 9.3 (SAS Inc., Chicago, IL) program was used for statistical analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Brazilian,
- bedridden,
- of both genders,
- aged between 45 and 75 years old, and
- diabetic or not.
Exclusion Criteria:
- hyperglycemic volunteers, and
- those with pressure ulcers other than grade II.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gel with HPβCD-I complex
A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
|
Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer and covered with sterile gauze and a transparent film. The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation. |
ACTIVE_COMPARATOR: Gel with insulin
A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
|
Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film. The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation. |
PLACEBO_COMPARATOR: Control gel
A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.
|
Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film. The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Index (%EI)
Time Frame: 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.
|
Measured every 3 days for 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Graciette Matioli, Doctor, State University of Maringá
Publications and helpful links
General Publications
- Zhang L, Zhu W, Song L, Wang Y, Jiang H, Xian S, Ren Y. Effects of hydroxylpropyl-beta-cyclodextrin on in vitro insulin stability. Int J Mol Sci. 2009 May 6;10(5):2031-2040. doi: 10.3390/ijms10052031.
- Chaudhary H, Rohilla A, Rathee P, Kumar V. Optimization and formulation design of carbopol loaded Piroxicam gel using novel penetration enhancers. Int J Biol Macromol. 2013 Apr;55:246-53. doi: 10.1016/j.ijbiomac.2013.01.015. Epub 2013 Jan 31.
- Siritientong T, Angspatt A, Ratanavaraporn J, Aramwit P. Clinical potential of a silk sericin-releasing bioactive wound dressing for the treatment of split-thickness skin graft donor sites. Pharm Res. 2014 Jan;31(1):104-16. doi: 10.1007/s11095-013-1136-y. Epub 2013 Jul 31.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UEM-LaBE-01
- 0069.0.093.000-11 (OTHER_GRANT: Ethics in Research Involving Human Subjects (SISNEP))
- 035/2012 (OTHER_GRANT: Ethics in Research Involving Human Subjects (COPEP-UEM))
- 072/2013 (OTHER_GRANT: HUM-COREA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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