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| A study to determine whether a static magnetic device can promote chronic leg ulcer healing were completed and published in the Journal of Wound Care Volume 14, Number 2 (Feb 2005).
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"With the relatively few numbers of patients in the trial we were not expecting to observe such clear difference due to the magnetic device.... we felt that the results were of such potential importance that they merited publication at this stage. What is more significant is that these were all patients whose ulcers were failing to heal by other usual treatments".
Dr Nyjon Eccles (Lead clinician for the study).
- The results, even though based on 26 subjects, are very statistically valid and showed significance levels of p<0.01. As a general statistical point, large numbers of subjects are not necessary to detect large effects due to treatment. A statistical power test confirmed that to detect a difference of 30% in ulcer size would require 20 in each group. Average differences in ulcer size after 4Ulcercare (the chosen trademark for the trialled product) in the study were actually 90%, so you can appreciate that 26 subjects is a large enough sample size.
- My original study report runs to some 50 pages and had to be hugely condensed in order for the Journal to consider it for publication. More of the trial is available Ulcercare study on line – excluding the part published in the Journal of Wound Care (Feb 2005).
- Finally it is important to bear in mind that the results reported were achieved on patients whose chronic (average duration already 4 years) ulcers had been unresponsive to all other treatments.
Copies of the Journal of Wound Care are available for nurses by call our help line on 0117 9710 710 (office hours)
4Ulcercare Double blind placebo-controlled trial has now been completed by the NHS and has been published in the Journal of Wound Care (Feb 05). The interim report below was submitted prior to publication.
Interim clinical report
All 28 patients in this study had by definition chronic leg ulcers that had failed to heal after 12 weeks of usual evidence-based ulcer therapy, including compression. After the 12-week treatment period of the trial, that included a continuation of usual therapy, there was a statistically significant reduction in ulcer size in the Ulcercare group but not in the placebo group (p< 0.01). At least 30% of the Ulcercare group had complete healing of their ulcers after the 12 weeks. We would have to conclude from these results that the application of the Ulcercare device has the ability, over and above any healing produced by the usual evidence-based therapy, to expedite healing of chronic leg ulcers. On the basis of this evidence we would recommend that Physicians and Nurses trial this simply applied product on their patients with ulcers resistant to healing. Furthermore, it seems reasonable to suggest that Ulcercare may prove to be useful in expediting healing of non-chronic leg ulcers and the current results, I believe, would justify a larger trial to investigate this.
Dr Nyjon Eccles BSc MBBS PhD MRCP
To Purchase the the Magnopulse Ulcercare, Click Here
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