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

Abstract

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.

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: A systematic review

“…We found one study comprising 324 participants, which was assessed as being at moderate risk of bias, which evaluated the efficacy of diperoxochloric acid as a topical solution compared with isotonic sodium chloride solution in diabetic foot ulcers. 29 It reported a significantly greater proportion achieving complete wound healing at 10 weeks, but offloading was not standardised and the results of the a per protocol analysis were reported only. Participants were mainly hospitalised and thus the generalisability of this result is unclear.…”

“…Four of the above studies also reported time to healing 23,26,27,29 with a further study 32 investigating time to healing using a gentamicin sponge.…”

“…We identified 12 studies which investigated the use of either antiseptics or antimicrobials and reported our chosen outcomes. Five of these used silver containing dressings or applications, [21][22][23][24][25] three iodine containing dressings/applications, [26][27][28] a single study of Diperoxochloric acid (DPOCL), 29 a single study of a superoxidised solution 30 and two studies of gentamicin impregnated sponges. 31,32 Outcome: Complete wound healing Silver (or silver impregnated).…”

“…Diperoxochloric acid. One study identified of this intervention 29 reported time to healing. Although a shorter time to healing was reported compared to the control arm, no between group statistical analyses were reported and only results of the per-protocol analysis were reported.…”

Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update)

“…Given this is a large group of interventions, we have broken down the key recommendations into smaller sections based on the groups of types of products and applications currently available. Rationale: We found 12 studies [27][28][29][30][31][32][33][34][35][36][37][38] evaluating anti-septic or antimicrobial dressings or topical antiseptic applications. Five evaluated the use of silver impregnated dressings in comparison with usual care [27][28][29][30]37 but all were considered at high or moderate risk of bias.…”