ArticleClinical diabetes and endocrinology2016
The role of chloramines in treatment of diabetic foot ulcers: an exploratory multicentre randomised controlled trial.
Article in Clinical diabetes and endocrinology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Topical antimicrobial agents for treating foot ulcers in people with diabetes.The Cochrane database of systematic reviews · 2017Pooled it
- Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine - a one-year randomized clinical trial study.Acta odontologica Scandinavica · 2024Trial
- Modelling the cost-effectiveness of a chloramine gel in treating infected, non-healing diabetic foot ulcers.Health science reports · 2024Article
- Adjunctive Application of Hyaluronic Acid in Combination with a Sodium Hypochlorite Gel for Non-Surgical Treatment of Residual Pockets Reduces the Need for Periodontal Surgery-Retrospective Analysis of a Clinical Case Series.Materials (Basel, Switzerland) · 2022Article
- Update on management of diabetic foot ulcers.Annals of the New York Academy of Sciences · 2018Review
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic foot ulcers in diabetes are serious, costly and frequently difficult to heal. Recent guidelines conclude that new dressings and treatments generally fail to show superiority compared with standard of care. Several mechanisms are probably responsible for impaired healing of chronic foot ulcers, including inflammation and infection. Chloramines have presumed antiseptic and antibacterial properties, and have shown to be a useful treatment in odontology.
methodsIn an explorative open randomised controlled multi-centre study, we compared chloramine-based treatment with current standard of care for 12 weeks and follow-up for 24 weeks. Seventeen patients in each group, mean age about 70, duration of diabetes > 20 years and foot ulcers about 1.5 years, completed the 12 weeks study.
resultsAfter 5 weeks, the difference between the groups in relative reduction in ulcer area was statistically significant (p=0.016). Absolute change in ulcer area was first statistically significant within the chloraminetreated group after 2 weeks (p=0.026), after 8 weeks in the control group (p=0.0023), with significant difference between groups after 5 weeks (p=0.024). The approximate relative decrease per week was 19.4% (95%CI 12.2, 26.0; p<0.0001) in the chloramine-treated group and 11.7% (95%CI 6.4, 16.7; p<0.0001; between-group difference p=0.083). After 9 weeks 7 patients had healed in the chloraminetreated group, but only one in the control group (p=0.039). There were no statistically significant differences in wound healing at 12 or 24 weeks, and no marked differences in signs of infection, pain, quality of life (EQ-5D), or incidence of adverse events.
conclusionsChloramine-based treatment seems to be efficacious, particularly in the early phase of the care of infected diabetic foot ulcers. It is safe and easy to use, and could prove to be a valuable addition in the treatment arsenal, providing non-surgical debridement. Future studies will evaluate its role in wound care.
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