Effects of intravenous Semelil (ANGIPARS™) on diabetic foot ulcers healing: A multicenter clinical trial

Abstract

Some diabetic foot ulcers, which are notoriously difficult to cure, are one of the most common health problems in diabetic patients .There are several surgical and medical options which already have been introduced for treatment of diabetic foot ulcers, so some patient will require amputation. The purpose of this study was to evaluate the efficacy of intravenous Semelil (ANGIPARS™), a naive herbal extract to accelerate healing of diabetic foot ulcers. A multi-centric randomized controlled trial was conducted to evaluate intravenous Semelil for healing of diabetic foot ulcers. Sixteen diabetic patients were treated with intravenous Semelil, and nine other patients were treated with placebo as control group. Both groups were otherwise treated by wound debridement and irrigation with normal saline solution, systemic antibiotic therapy and daily wound dressing. Before and after intervention, the foot ulcer surface area was measured, by digital photography, mapping and planimetry. After 4 weeks, the mean foot ulcer surface area decreased from 479.93±379.75 mm2 to 198.93±143.75 mm2 in the intervention group (p = 0.000) and from 766.22±960.50 mm2 to 689.11±846.74 mm2 in the control group (p = 0.076). Average wound closure in the treatment group was significantly greater than placebo group (64% vs. 25%, p= 0.015). This herbal extract by intravenous rout in combination with conventional therapy is more effective than conventional therapy by itself probably without side effect. However, further studies are required in the future to confirm these results in larger population.