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Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT02789033
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Leonel Garcia Benavides, University of Guadalajara

Brief Summary:
The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition is more frequent in elder patients. It is estimated that about 5% of all patients with diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while 10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb amputation could also be involved in a new amputation in the next year; higher or in the other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading device, wound care and surgery in selected cases. However, treatment of DFU remains challenging because of unsatisfactory results from surgical and non-surgical treatments. Many adjunctive therapies are designed to improve the care of DFU including negative pressure wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB) Hyperbaric oxygen and acellular matrix product among others.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: Chitosan Drug: Isosorbide dinitrate Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chitosan
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
Drug: Chitosan
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
Other Name: polymers

Drug: Isosorbide dinitrate
Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate
Other Name: organic nitrate

Active Comparator: Isosorbide dinitrate spray
Isosorbide dinitrate spray (2.5 mg) is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate.
Drug: Chitosan
Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
Other Name: polymers

Drug: Isosorbide dinitrate
Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate
Other Name: organic nitrate

Placebo Comparator: Placebo
Placebo in the same pharmacological presentation
Drug: Placebo
placebo
Other Name: Magnessium Calcuim




Primary Outcome Measures :
  1. Biopsies [ Time Frame: 6 months ]
    Histological changes in ulcers



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with another type of topical medication
  • patients with diabetic foot ulcers in grade III and
  • with leg arm index <0.8

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789033


Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Leonel Garcia, PhD University of Guadalajara
Additional Information:
Publications:

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Responsible Party: Leonel Garcia Benavides, Professor researcher, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02789033    
Other Study ID Numbers: 030-2010
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Leonel Garcia Benavides, University of Guadalajara:
diabetic foot ulcers
chitosan
isosorbide dinitrate spray
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Chitosan
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents