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

NCT02789033 | Completed Phase 3 Results DMC

• 1 other identifier: 030-2010
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot Ulcers

Keywords

diabetic foot ulcers; chitosan; isosorbide dinitrate spray

Outcome Measures

Primary Outcomes (1)

• Biopsies

  Histological changes in ulcers

  75 days

Study Arms (3)

Chitosan

ACTIVE COMPARATOR

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; Drug: Isosorbide dinitrate

Isosorbide dinitrate spray

ACTIVE COMPARATOR

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; Drug: Isosorbide dinitrate

Placebo

PLACEBO COMPARATOR

Placebo in the same pharmacological presentation

Drug: Placebo

Interventions

Chitosan DRUG

Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine

Also known as: polymers

Chitosan; Isosorbide dinitrate spray

Isosorbide dinitrate DRUG

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

Also known as: organic nitrate

Chitosan; Isosorbide dinitrate spray

Placebo DRUG

placebo

Also known as: Magnessium Calcuim

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Guadalajara: lead

Related Publications (11)

• Alexiadou K, Doupis J. Management of diabetic foot ulcers. Diabetes Ther. 2012 Nov;3(1):4. doi: 10.1007/s13300-012-0004-9. Epub 2012 Apr 20.

  PMID: 22529027 BACKGROUND

• Reiber GE, Lipsky BA, Gibbons GW. The burden of diabetic foot ulcers. Am J Surg. 1998 Aug;176(2A Suppl):5S-10S. doi: 10.1016/s0002-9610(98)00181-0.

  PMID: 9777967 BACKGROUND

• Xie X, McGregor M, Dendukuri N. The clinical effectiveness of negative pressure wound therapy: a systematic review. J Wound Care. 2010 Nov;19(11):490-5. doi: 10.12968/jowc.2010.19.11.79697.

  PMID: 21135797 BACKGROUND

• Tiaka EK, Papanas N, Manolakis AC, Maltezos E. The role of hyperbaric oxygen in the treatment of diabetic foot ulcers. Angiology. 2012 May;63(4):302-14. doi: 10.1177/0003319711416804. Epub 2011 Aug 25.

  PMID: 21873346 BACKGROUND

• Schaffer MR, Tantry U, Efron PA, Ahrendt GM, Thornton FJ, Barbul A. Diabetes-impaired healing and reduced wound nitric oxide synthesis: a possible pathophysiologic correlation. Surgery. 1997 May;121(5):513-9. doi: 10.1016/s0039-6060(97)90105-7.

  PMID: 9142149 BACKGROUND

• Andrews KL, Irvine JC, Tare M, Apostolopoulos J, Favaloro JL, Triggle CR, Kemp-Harper BK. A role for nitroxyl (HNO) as an endothelium-derived relaxing and hyperpolarizing factor in resistance arteries. Br J Pharmacol. 2009 Jun;157(4):540-50. doi: 10.1111/j.1476-5381.2009.00150.x. Epub 2009 Mar 26.

  PMID: 19338582 BACKGROUND

• Raafat D, von Bargen K, Haas A, Sahl HG. Insights into the mode of action of chitosan as an antibacterial compound. Appl Environ Microbiol. 2008 Jun;74(12):3764-73. doi: 10.1128/AEM.00453-08. Epub 2008 May 2.

  PMID: 18456858 BACKGROUND

• Sezer AD, Cevher E, Hatipoglu F, Ogurtan Z, Bas AL, Akbuga J. Preparation of fucoidan-chitosan hydrogel and its application as burn healing accelerator on rabbits. Biol Pharm Bull. 2008 Dec;31(12):2326-33. doi: 10.1248/bpb.31.2326.

  PMID: 19043221 BACKGROUND

• Girach A, Manner D, Porta M. Diabetic microvascular complications: can patients at risk be identified? A review. Int J Clin Pract. 2006 Nov;60(11):1471-83. doi: 10.1111/j.1742-1241.2006.01175.x.

  PMID: 17073842 BACKGROUND

• Chabbert-Buffet N, LeDevehat C, Khodabandhelou T, Allaire E, Gaitz JP, Tribout L, Abdoucheli-Baudot N, Vayssairat M. Evidence for associated cutaneous microangiopathy in diabetic patients with neuropathic foot ulceration. Diabetes Care. 2003 Mar;26(3):960-1. doi: 10.2337/diacare.26.3.960. No abstract available.

  PMID: 12610079 BACKGROUND

• Richards AM, Floyd DC, Terenghi G, McGrouther DA. Cellular changes in denervated tissue during wound healing in a rat model. Br J Dermatol. 1999 Jun;140(6):1093-9. doi: 10.1046/j.1365-2133.1999.02908.x.

  PMID: 10354076 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Chitosan; Polymers; Isosorbide Dinitrate; Glutathione Transferase

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Isosorbide; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: PhD. Leonel García Benavides
• Organization: Universidad de Guadalajara

drleonelgb@hotmail.com

+52 (33) 20 00 23 00

Study Officials

• Leonel Garcia, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor researcher

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: June 2, 2016
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share