SLR - December 2014 - Steven O'Bryant
Reference: Awsakulsutthi S, Punpho K, Mamom J, Baikrut P, Yingchoorod P. Beraprost Sodium for Chronic Diabetic Foot Ulcer: A Randomized Controlled Trial in Thammasat University Hospital. Ann Vasc Dis. 2014; 7(1): 40-5.
Scientific Literature Review
Review by: Steven O'Bryant, DPM
Residency Program: Saint Francis Hospital and Medical Center, Hartford, CT
Podiatric Relevance: The diabetic foot ulcer is a major problem for those affected as well as a huge economic burden on the health care system. In 2001, diabetes-related foot ulcers and amputations cost the US health care payers an estimated $11 billion. Diabetic foot ulcers often require a multidisciplinary approach to treatment. Podiatrists, as well as other wound care specialists, have performed numerous studies on various treatment modalities for the chronic diabetic foot ulcer. Beraprost Sodium (a prostaglandin I2 analog) is another potential option for the treatment of these chronic ulcers.
Methods: Fifty chronic diabetic foot ulcer patients were enrolled in this study. Inclusion criteria were established diagnosis of DM, unhealed foot ulcers for more than three weeks. Exclusion criteria were ABI < 0.9, history of DVT, bleeding abnormality, active infection, abnormal bleeding time, liver function, or serum creatinine. The 50 patients were divided into two groups, a control group, which received placebo, and a study group which received daily Beraprost Sodium (BPS). Patients in the treatment group received 60-120 µg/day. Both groups received local wound care consisting of normal saline cleansing and the application of Intrasite gel. Wound measurements were taken at two weeks, four weeks, and six weeks, to compare healing between the two groups.
Results: Rate of wound healing at two weeks, four weeks, and six weeks, was 35.6 percent, 67.8 percent, and 85.8 percent in the study group and 20.1 percent, 30.3 percent, and 41.5 percent in the control group. At the end of the sixth week the median wound healing rate in the study group was 88.1 vs 33.3 in the control group, p <0.001. Complete healing in the study group at the end of the 6 weeks was 48 percent compared to 8percent in the control group, p <0.001.
Conclusions: PGI2 causes anti-platelet aggregation, vasodilatation, and improves endothelial function and serum glucose. BPS is a chemically stable PGI2 analogue that is given in an oral form. The study group received daily BPS and showed significant improvement in DFU healing rates over the placebo group. The most common side effects reported from BPS were headache (58.3 percent) and palpitation (4.17 percent. BPS remains a viable option in the treatment of chronic diabetic foot ulcers when ulcers are not infected, and when patients have adequate blood supply or are poor revascularization candidates.