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,...

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Published in:International journal of lower extremity wounds 2024-12, Vol.23 (4), p.551-559
Main Authors: Bal, Arun, Jain, Sudhir Kumar, Jagannath, Mohapatra, Kailash Chandra, Rao, Shilpa, Deshpande, Neeta, Munshi, Renuka, Mahey, Rajeshkumar, Chowdhury, Subhankar, Bhaskar, M.M., Singh, Sapam Opendro, Damle, Gauri, Damir, Ashok, Phal, Smita, Zarapkar, Mukund
Format: Article
Language:English
Subjects:
Administration, Topical
Adult
Aged
Diabetic Foot - drug therapy
Double-Blind Method
Female
Humans
Male
Middle Aged
Treatment Outcome
Wound Healing - drug effects
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container_title International journal of lower extremity wounds
container_volume 23
creator Bal, Arun
Jain, Sudhir Kumar
Jagannath
Mohapatra, Kailash Chandra
Rao, Shilpa
Deshpande, Neeta
Munshi, Renuka
Mahey, Rajeshkumar
Chowdhury, Subhankar
Bhaskar, M.M.
Singh, Sapam Opendro
Damle, Gauri
Damir, Ashok
Phal, Smita
Zarapkar, Mukund
description 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
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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 &lt;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. 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subjects Administration, Topical
Adult
Aged
Diabetic Foot - drug therapy
Double-Blind Method
Female
Humans
Male
Middle Aged
Treatment Outcome
Wound Healing - drug effects
title 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
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