Volume 1 • Issue 2 • 1000e104 J Biomol Res Ther ISSN: 2167-7956 JBMRT, an open access journal Open Access Editorial Aalaa et al., J Biomol Res Ther 2012, 1:2 DOI: 10.4172/2167-7956.1000e104 Introduction Diabetes Mellitus is a most common metabolic disease in the world cause around 15% of diabetic patients sufer from Diabetic Foot Ulcer (DFU) in which 15-20% will lead to amputation [1,2]. Regardless of diferent types of diabetic foot ulcer treatment the incidence of lower extremities amputation among diabetics is still high [3]. In this regard ANGIPARS™ as a novel safe herbal formulation has been presented for diabetic foot ulcer. Results of studies which evaluate the efectiveness the main substance (Melilotus) of this product revealed not only it is ef- fective in elimination of skin aging and stimulate microvascularization but also it has anti-infammatory efects [4,5]. Clinical Trial Studies Preclinical, experimental study In this phase, the acute toxicity, genotoxicity, apoptotic efects, sub acute toxicity, mutagenic efects, fetal toxicity, and allergic efects of ANGIPARS™ have been evaluated and there was not any acute or chronic toxicity so that it was recommended for clinical studies [6,7]. Phase I clinical trial study In frst phase of the clinical trial, both Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of ANGIPARS™ were studied in which intravenous injection of 10 cc per day ANGIPARSTM causes the signifcant improvement of the foot ulcer. In this phase there was not any clinical or laboratory adverse efects except the phlebitis in the site of injection. In other word the only adverse efect seen with dose of 13.5 cc per day. Consequently, the MTD of 10 cc per day and the only DLT of phlebitis were reported [8]. Phase II clinical trial study In a second phase of clinical trial, the safety and efcacy of parentral ANGIPARS™ in healing diabetic foot ulcer was studied by Endocrine and Metabolic Diseases Research Centre of Tehran University of Medi- cal Sciences. Te results were evidence for an efect drug of at least 50% in decreasing wound size [9]. Phase III clinical trial study In a multicentre phase III study, the intravenous ANGIPARS™ study, patients as an intervention group were treated by intravenous ANGIPARS™ 4cc daily for 4 weeks. Te drug diluted in 50-100 cc nor- mal saline and infused during 30-60 minutes. It showed that foot ulcer surface area decreased in the intervention compared with control group with conventional therapy. In other word the wound healing percent was 64% for ANGIPARS™ [10]. Patients were randomized into one of 2 experimental or a control group. Te frst experimental group was patients received 100 mg of ANGIPARS™ capsules orally twice a day for 6 weeks and the second experimental group, additionally to the mentioned oral therapy, 3% gel was administered topically beside of all standard wound treatments in both group. While the control group was treated with standard wound care. Te wound in 83-100% of patients who received oral-topical form of ANGIPARS™ completely improved whereas the rate of complete clo- sure was 22% in control group [11]. Phase IV clinical trial study (Post-marketing) In Post-Marketing study patients administered 100 mg of AN- GIPARS™ capsules orally twice a day plus topical 3% gel for 45 days. Mean ulcer surface area considerably decreased. In addition there was a signifcant rise in Ankle Brachial Index (ABI) and Toe Brachial Index (TBI) afer treatment period. It should be noted that there was not any signifcant side efects or toxicity during the Post-Marketing study. Conclusion ANGIPARS™ as a novel herbal formulation, presented for treatment of diabetic foot ulcer. Taking into account the efcacy and safety of AN- GIPARS™ which has evaluated through multicentre double blind pla- cebo controlled phases of trials and its very few toxic efects, efective- ness in diabetic foot ulcer healing, decreasing wound size along with enhancing microvascularization, it could be recommended in diabetic foot ulcer treatment. On the other word ANGIPARS™ along with other modality could be helpful in diabetic foot ulcer treatment especially when other treatments have not been efective. Finally it should be not- ed that use of ANGIPARS™ along with other treatments and debride- ment would be more efective. References 1. Introduction: Diabetes in the Eastern Mediterranean Region. 2. American Diabetes Association (1999) Consensus development conference on diabetic foot wound care 7-8 April 1999, Boston, Massachusetts. Diabetes Care 22: 1354-1360. 3. Morris AD, McAlpine R, Steinke D, Boyle DI, Ebrahim AR, et al. (1998) Diabe- tes and lower-limb amputations in the community. A retrospective cohort study. DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scot- land/Medicines Monitoring Unit. Diabetes Care 21: 738-743. 4. Asres A, Eder U, Bucar F (2000) Studies on the anti-infammatory activity of axtracts and compounds from the leaves of Melilotus elegans. Ethiopian Phar- maceutic J 18: 15-24. 5. Plesca-Manea L, Parvu AE, Parvu M, Taamas M, Buia R, et al. (2002) Effects of Melilotus offcinalis on acute infammation. Phytother Res 16: 316-319. 6. Khorram Khorshid HR, Sadeghi B, Heshmat R, Abdollahi M, Salari P, et al. (2008) In vivo and In vitro genotoxicity studies of Semelil (ANGIPARS™). DARU J Pharm Sci 16: 20-24. 7. Abdollahi M, Farzamfar B, Salari P, Khorram Khorshid HR, Larijani B, et al. (2008) Evaluation of acute and sub-chronic toxicity of Semelil (ANGIPARS™), a new phytotherapeutic drug for wound healing in rodents. DARU 16: 7-14. 8. Heshmat R, Mohammad K, Mohajeri Tehrani MR, Tabatabaie Malazy O, Kes- *Corresponding author: Mohajeri-Tehrani MR, Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences, Tehran, E-mail: mrmohajeri@tums.ac.ir Received March 17, 2012; Accepted March 19, 2012; Published March 24, 2012 Citation: Aalaa M, Heshmat R, Larijani B, Mohajeri-Tehrani MR (2012) Smelil (ANGIPARS™) as a New Herbal Drug on Diabetic Foot Ulcer. J Biomol Res Ther 1:e104. doi:10.4172/2167-7956.1000e104 Copyright: © 2012 Aalaa M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Smelil (ANGIPARS™) as a New Herbal Drug on Diabetic Foot Ulcer Aalaa M, Heshmat R, Larijani B and Mohajeri-Tehrani MR* Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences, Tehran Journal of Bioresearch Communications J o u r n a l o f B i o m o l e c u l a r R e s e a r c h & T h e r a p e u t i c s ISSN: 2167-7956