Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Description:
A randomized, placebo controlled, double-blind Clinical trial was designed. 60 Patients with
diabetic foot ulcers in grade I and II of the classification of Wagner, with leg arm index>
0.8 and without specific treatment for foot ulcers referred to the experimental and clinical
Therapeutic Institute will be included. All patients give written informed consent;
previously the protocol was approved for the bioethics committee of the CUCS, of the
Guadalajara University, registration number 030-2010. Patients with another type of topical
medication will be excluded. Isosorbide dinitrate spray (2.5 mg).
Preparation of chitosan Hydrogels: The composition of gel formulation will be given prior
training. ISDN and chitosan gel will be applied handled under aseptic conditions to the
wound, and covered with sterile bandages. The patients will be evaluated every 2 weeks
(macroscopic study and measurement of the ulcerated area) until 6 views. A second biopsy will
be done one week before the finalization of the treatment of 15 weeks. The biopsies will be
embedded on paraformaldehyde (4%) and paraffin. Sections of 5 µm were analyzed by a
pathologist to determine hypertrophic and hyperplasic capillaries, inflammation and cellular
matrix using Hematoxylin & eosin and Masson’s trichrome stains. An immunohistochemical stain
was also realized to evaluate several molecular markers such as α-SMA (abcam, Cambridge, MA),
Desmin (abcam, Cambridge, MA), VEGF (abcam, Cambridge, MA) and Von Willebrand Factor
(Chemicon, CA). (figure 1) Statistical analysis: It will be done using SPSS program for
Windows Version 10.0, the results of quantitative variables were expressed in average and
standard deviation. The differences between baseline and subsequent pharmacologic
intervention measurements will be investigated with the Wilcoxon test. The Mann Whitney U
test will be used to compare groups. Frequencies by categories as well as percentages will be
quantified for qualitative variables. Comparisons between groups were performed with Chi2.
For all comparisons p < 0.05 will be considered as significant.
Condition:
Diabetic Foot Ulcers
Treatment:
Chitosan
Start Date:
June 2015
Sponsor:
University of Guadalajara
For More Information:
https://clinicaltrials.gov/show/NCT02789033