Cover Image

Randomized double blind placebo – controlled trial of doxium in diabetic foot infection

Fatemeh Ahmadi, Reza Shahrami, Shokrollah Salmanzadeh*

Abstract


Foot infection is the most common cause of extremity loss in diabetic patients. Doxium (calcium dobesilate) has antioxidant and anti-endothelin effects and improve blood supply. We assessed doxium as adjunctive drug for treatment of foot infection in diabetic patients. 64 diabetic patients with foot infection in grade 3 of Wagner classification were enrolled in a double blind placebo-controlled study. Patients were randomly assigned doxium therapy (trial n=32) or placebo (control n=32) for 30 days. Both groups received similar antibiotic and insulin treatment. Resolution time of infection, need to surgery, ankle/brachial index (ABI) and transcutaneous oxygen (TCO) were measured in two groups. Doxium therapy was associated with quicker resolution of infection and shorter time of antibiotic therapy (trial= 20.7 days vs. control= 25.4 days, P<0.01). On day 15th of treatment, 9.38% (3 patients) of trail and 34% (11 patients) of control (p < 0.02), needed surgical debridement, but there were no significant differences between two group at the end of study (day 30).  Also we did not find, decreasing ABI over time is significant (0.10, P<0.001) but were similar among trail (from day 1 ABI= 0.96±0.04) and control groups (from day 1 ABI= 0.92± 0.04). Also study found TCO rose significantly in trail (from 73.8±11.3 to 79.50 mmHg) and control (from 66.60 to 70.40 mmHg) groups. Doxium can accelerate healing of diabetic foot infection in combination with antibiotic therapy. The mean time of infection resolution and antibiotic therapy decreased 4.7 days in doxium group compared with placebo group. Intervention could not raise the TCO pressure and also change in ABI in this study.

Keywords


Doxium; Diabetes Mellitus; Foot infection

Full Text:

PDF

References


Powers AC: Diabetes Mellitus. In Harrison's Principles of Internal Medicine. New York: McGraw-Hill Medical; 2008: 2292.[edition t (Series Editor)

Berbari F, Steckelberg JM, Osmon DR: Osteomyelitis in in Mandell's principles and practice of infectious disease. Philadelphia: Churchill Living Stone; 2010: 1461

Dezfulian A, Salehian MT, Amini V, Dabiri H, Azimi Rad M, Aslani MM, Alebouyeh M, Fazel I, Zali MR: Bacteriological study of diabetic foot infections in an Iranian hospital. Iranian Red Crescent medical journal 2011, 13:590-591.

Powers AC: Diabetes mellitus. In Harrison's Principles of Internal Medicine. New York: McGraw-Hill Medical; 2008: 2153-2169

Wunderlich RP, Peters EJ, Lavery LA: Systemic hyperbaric oxygen therapy: lower-extremity wound healing and the diabetic foot. Diabetes care 2000, 23:1551-1555.

Grolman RE, Wilkerson DK, Taylor J, Allinson P, Zatina MA: Transcutaneous oxygen measurements predict a beneficial response to hyperbaric oxygen therapy in patients with nonhealing wounds and critical limb ischemia. The American surgeon 2001, 67:1072-1079; discussion 1080.

Cruciani M, Lipsky BA, Mengoli C, de Lalla F: Granulocyte-colony stimulating factors as adjunctive therapy for diabetic foot infections. Cochrane database of systematic reviews (Online) 2009:CD006810.

Tejerina T, Ruiz E: Calcium dobesilate: pharmacology and future approaches. General pharmacology 1998, 31:357-360.

Martinez-Zapata MJ, Moreno RM, Gich I, Urrutia G, Bonfill X: A randomized, double-blind multicenter clinical trial comparing the efficacy of calcium dobesilate with placebo in the treatment of chronic venous disease. European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 2008, 35:358-365.

Carneiro A, Golay A, Cozma G, Caillon P, Castro-Correia J: Efficacy of Doxium (R) on the Blood-Retinal Barrier Permeability in Early Diabetic Retinopathy Independently of Diabetic Control. Investigative Ophthalmology and Visual Science 2004, 45:4109.

Leite E, Mota M, Abreu JF, Cunha-Vaz J: Effect of calcium dobesilate on the blood-retinal barrier in early diabetic retinopathy. International ophthalmology 1990, 14:81-88.

Junwu D, Xiaochen L, Shenwei L, Mingbo L, Yanmei X, Bing C: Effects of calcium dobesilate on glomerulus TIMP1 and collagen IV of diabetic rats. Journal of Huazhong University of Science and Technology--Medical Sciences-- 2005, 25:416-418.

Cortelekoglu T, Bozkurt A, Ustundag N, Koksal C, Sayin A: The effects of clopidogrel and calcium dobesilate on intimal hyperplasia following vascular injury. Acta chirurgica Belgica 2006, 106:206.

Ishikawa SN: Diabetic foot. In Campbell's operative orthopaedics. Volume 11: Mosby Elsevir 2008: 4700

Pasternack MS, Swartz MN: Cellulitis, Necrotizing Fasciitis, and Subcutaneous Tissue Infections. In Mandell's principles and practice of infectious disease. Volume 7. Philadelphia: Churchill Living Stone; 2010: 1302

Peripheral IO: Peripheral arterial disease in people with diabetes. Diabetes care 2003, 26:3333.




DOI: http://dx.doi.org/10.21746/ijbio.2015.08.006

Refbacks

  • There are currently no refbacks.




Copyright (c) 2015 International Journal of Bioassays

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

International Journal of Bioassays is a member of the Publishers International Linking Association, Inc. (PILA), CROSSREF and CROSSMARK (USA). Digital Object Identifier (DOI) will be assigned to all its published content.