RESUMEN
Diabetes mellitus is the most common human metabolic disease and chronic non healing diabetic foot ulcers are a critical complication for these patients. ANGIPARS is a new herbal extract which has been introduced to accelerate healing of these ulcers. The purpose of this study was to investigate the efficacy and safety of oral ANGIPARS in patients with chronic diabetic foot ulcers and also its effect on inflammatory blood markers. In a double-blind placebo-controlled trial, 40 patients with diabetic foot ulcers of at least 4 weeks duration, were randomized to receive either oral ANGIPARS, or placebo twice a day, until the ulcer was completely healed or for a maximum of 6 weeks and followed up to 12 weeks. Standard foot ulcer care was given to all patients. The healing process was assessed with measuring ulcer surface area and time needed to achieve complete wound healing. Drug safety was assessed by monitoring adverse events, using clinical and laboratory evaluations. In both groups, wound surface area decreased significantly [p<0.0005]. Mean improvement ratio was 95.8% in the ANGIPARS group and 79.2% in the placebo group, although mean percent of wound area reduction in the former group was higher than in the placebo group at weekly assessments, this difference was not statistically significant [p=0.25] except for at the 4[th] week. [84/2% vs. 56%, p=0.013] Ultimately, complete wound healing was achieved in 90% and 70% of ANGIPARS group and placebo group, respectively, after 12 weeks. Time to achieve complete wound healing, also, was not different significantly in either groups. [6.2 vs 7.4 weeks, p=0.3] Significant reduction in ESR was sent in the ANGIPARS group. [p=0.04] There was no significant changes in laboratory parameters. Two complications most likely attributable to ANGIPARS reported were worsening of proliferative diabetic retinopathy in one patient and acute renal failure and acute hepatitis in another patient with diabetic nephropathy. Although ANGIPARS enhanced wound healing at least within weeks 2 to 4 of treatment, we did not observe a significant effect in the outcome. Therefore, standard foot ulcer care seems to be the cornerstone of diabetic foot ulcer management and ANGIPARS should probably be reserved for treatment of the non-healing or difficult-to-heal ulcers that do not respond to standard treatments. Further studies are required to assess the efficacy of this new herbal extract