Efficacy of Cadexomer Iodine in the Treatment of Chronic Ulcers: A Randomized, Multicenter, Controlled Trial.

Abstract

INTRODUCTION:

Due to being hard to heal, chronic ulcers account for high morbidity.

OBJECTIVE:

This study compares the safety and efficacy of 2 formulations of cadexomer iodine and standard care for the treatment of chronic ulcers.

MATERIALS AND METHODS:

This prospective, randomized, open-label clinical trial was conducted at 8 cities across 15 institutions in India from March 2016 to March 2017. After screening a total of 145 patients with chronic, recalcitrant ulcers, 124 were randomized to 1 of 3 treatments: 0.9% cadexomer iodine ointment plus standard care (n = 41), 0.9% cadexomer iodine powder plus standard care (n = 43), and standard care alone (n = 40). All patients completed the maximum treatment period of 12 weeks, with the exception of 8 who discontinued during the study period. At the end of the treatment period, endpoints were assessed.

RESULTS:

The percentage of reduction in ulcer size from baseline to the primary endpoint of 12 weeks was significantly higher with both formulations of cadexomer iodine ointment (94.3% ± 10.6%) and powder (90.4% ± 14.9%) as compared with standard care alone (67.8% ± 21.8%). The percentage of patients with complete wound healing at the end of the 12 weeks was significantly higher in patients treated with both formulations of cadexomer iodine ointment (65.8%) and powder (58.1%) as compared with standard care alone (20.0%).

CONCLUSIONS:

These results demonstrate that cadexomer iodine, in comparison with standard care alone, increases the percentage of reduction in ulcer size and promotes complete wound healing in chronic ulcers.

• Authors: Radhakrishnan Raju, Sunil Naik Kethavath, Satyanarayana Murthy Sangavarapu, Praveen Kanjarla
• Journal: Wounds : a compendium of clinical research and practice (Wounds) Vol. 31 Issue 3 Pg. 85-90 (Mar 2019) ISSN: 1943-2704 [Electronic] United States
• PMID: 30720444 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents, Local
• Iodophors
• Ointments
• Powders
• cadexomer iodine

Topics

• Adult
• Anti-Infective Agents, Local (administration & dosage, pharmacology, therapeutic use)
• Chronic Disease (drug therapy)
• Debridement
• Female
• Humans
• India
• Iodophors (administration & dosage, pharmacology, therapeutic use)
• Male
• Middle Aged
• Ointments
• Powders
• Prospective Studies
• Treatment Outcome
• Ulcer (drug therapy, pathology)
• Wound Healing (drug effects, physiology)
• Young Adult