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Study aim
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Determining the effectiveness of Plantago major topical gel in the healing of diabetic foot ulcer and bedsore
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Design
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Two arm parallel group randomised trial with control group
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Settings and conduct
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The study will be performed in Al-Zahra hospital of Isfahan. Patients with the inclusion criteria will be randomly assigned to drug (Plantago major) or control groups. For patients in drug group, Plantago extract 10% topical gel will be applied for two weeks, while for patients of control group, specific dressing (Aquacel-Ag) will be used for two weeks. Before any intervention, the wound size as the product of the longest length and width as well as the presence or absence of erythema around the wound will be determined and recorded. At the end of 7th and 14th day of intervention, the percent of wound size reduction and the erythema status will be recorded. Furthermore, the number of cases with complete wound healing during the study will be recorded for both groups. Finally, the mentioned variables will be compared between the groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Age of 18 years-old or more
2. Diabetic foot ulcer grade 1 or 2 or bedsore stage 2 or 3
Exclusion criteria:
1. Smoking
2. Coagulopathy
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Intervention groups
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Drug Group: Plantago extract 10% topical gel (made by faculty of pharmacy of Isfahan university of medical sciences), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks
Control Group: Specific dressing (Aquacel-Ag, made by Convatec company, USA), once daily concurrent with routine wound care including irrigation with normal saline solution, dressing, and antibiotic administration, if necessary, for two weeks
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Main outcome variables
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1. The percent of decrease in the wound size
2. The number of cases of complete wound healing