Vol. 45 | No. 1 | January-June 2017 Back

Open Access

Sulodexide as an Adjunct for the Management of Venous Ulcers: A Meta-analysis

Joseph Marc Seguban, Michelle Andrea Uy-Reyes, Allan Lim, Elaine Alajar, Noemi Pestaño, Felix Eduardo Punzalan, Bernadette Tumanan-Mendoza
Jun 2017 DOI 10.69944/pjc.71188b6946

Abstract

Background: Venous leg ulcer is a common, chronic recurring condition that causes pain and disability. If not  treated, it can lead to severe infection and malignant transformation. Sulodexide is a highly purified glycosaminoglycan with anti-thrombotic, anti-fibrinolytic and anti-inflammatory properties that make it a suitable agent for the management of venous leg ulcers. At present, there is insufficient evidence to support the efficacy of the use of sulodexide in the management of venous leg ulcers and ulcer pain. 

Objective: This meta-analysis aims to determine the efficacy of sulodexide in the treatment of venous leg ulcers  in the promotion of complete ulcer healing and the reduction of pain. 

Methods: We selected studies with the following inclusion criteria: randomized controlled trials comparing  sulodexide with placebo in reducing pain and promoting complete ulcer healing among patients with venous leg ulcers. Both MESH and free text were used for searching text with the following terms: “sulodexide”, “venous ulcer”, “ulcer healing” and “ulcer pain”. The databases used were PubMed, MEDLINE and the Cochrane Central Register of Controlled Trials. Studies published in any language were eligible, without restrictions. The search was restricted to studies conducted with human participants. A review of all the included trials in recent meta-analyses that included sulodexide in the management of venous ulcers was also done. Full-text articles of the selected articles were obtained from websites of publications and collections of both local and international libraries. For articles not available online, correspondence with the author was done. Data on incomplete ulcer healing was extracted from each included trial to determine the reduction of incidences of incomplete ulcer healing among patients with venous leg ulcers, with the use of sulodexide for two and three months. Analysis was done using Review Manager software version 5.3, with heterogeneity measured using I2.  

Results: Four RCTs (n = 482) were included. Sulodexide was associated with significant reduction of  incomplete healing of venous leg ulcer. The pooled analysis at one month showed risk ratio of 0.77 (0.63 to 0.96) with p value of 0.06 and I2 = 71%. At two months, the data showed risk ratio of 0.71 (0.53 to 0.94) with p value of 0.15 and I2 = 47%. At three months, the data showed risk ratio of 0.66 (0.53 to 0.83) with p value of 0.04 and I2 = 77%.  

Conclusion: The results showed that sulodexide is an effective adjunct to wound care and compression therapy  in the management of venous ulcer within two months of use. The results also suggest a reduction in ulcer size as early as one month with further improvement in ulcer healing with continued use  for three months.  

Keywords: sulodexide, venous leg ulcers, ulcer healing, pain.

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