Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer: Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study.

Diabetic foot ulcer (DFU), if untreated, accounts for lower-limb amputations affecting patients' quality-of-life. Diperoxochloric acid (DPOCL) is known to heal DFU by its antibacterial and fibroblast stimulating activity. This was a phase 3, multicentre, randomized, double-blind, active-controlled, parallel-group study conducted to evaluate the efficacy and safety of topic solution of DPOCL compared with isotonic sodium chloride solution (ISCL). Adult patients with type 1 or 2 diabetes with random blood glucose levels of <250 mg/dL, with ≤ than three full-thickness foot ulcers were enrolled. Primary efficacy endpoint was complete wound closure and secondary was wound surface area. Adverse events were analyzed as safety endpoint. Of 311 enrolled patients, 289 were randomized 1:1 to DPOCL (139) and ISCL (150) treatment (10-weeks [8-Visits]). Percentage of patients with complete wound closure at visit-8, were significantly higher (P = .0156) in DPOCL arm (76% [105/139]) compared to ISCL (62% [93/150]) arm. At end-of-study, mean wound surface area in DPOCL arm (0.639 cm2) was significantly lower (P = .0209) compared to ISCL (0.818 cm2) arm. One death was reported in control arm which was not considered as treatment-related. No important safety finding were observed. Results indicate that, DPOCL can be considered as effective and safe treatment option for DFU compared to ISCL, although future confirmatory studies are warranted.

Carcinoma stomach: unwanted chemotherapeutic success: a case vignette.

A 45-years-old male, chronic smoker and occasional alcoholic, from Tamenlong district of Manipur was admitted to the department of Surgery, RIMS, Imphal on 19(th) August, 2011. He was diagnosed as a case of poorly differentiated adenocarcinoma of the stomach located at incissura along the lesser curvature. CT scan of abdomen had revealed para-aortic, aorto-caval and celiac lymphadenopathy. Patient had undergone 5 cycles of neo-adjuvant chemotherapy consisting of 3 weekly course of Oxaloplatin 80mg(D1) + epirubicin 200mg (D1) + Capicitabine 2000mg(D1-D14). After 1 month of chemotherapy, patient then underwent subtotal gastrectomy (modified D2 resection) without any significant peri-operative complication. Surprisingly, the final histopathological report of the resected specimen didnx't reveal any evidence of malignancy in any sections. Role of chemotherapy in gastric cancers has been an adjunct to surgery and the optimal drugs regimen has not been elucidated so far. Till now, very few cases of carcinoma stomach which show pathological complete response have been reported. Our case is such a rare case of pathological complete response following neoadjuvant chemotherapy.