Effectiveness of glyceryl trinitrate patches for people with impaired circulation in their feet: a randomised controlled trial
Effectiveness of glyceryl trinitrate patches on vascular perfusion and pain in ischaemic feet: a randomised controlled trial
Charles Sturt University
100 participants
Jan 3, 2012
Interventional
Conditions
Summary
Charles Sturt University is carrying out a research project on foot circulation in 2012-13. This is to determine if angina patch medication can help people with poor circulation to their feet. There is evidence to suggest that this patch treatment may be useful for many people by improving circulation to their feet and possibly also reducing pain and nerve damage associated with ischemia and diabetes. Reduced circulation to feet can be associated with problems such as foot ulcers, infection and amputations. The study involves about 100 volunteers who use a small dose patch on one foot and are monitored for the effects of this over 6 months of use. The effects on the circulation, the nerve function, wound healing and on foot pain in both feet will be checked. This study has the approval of the Charles Sturt University Human Research Ethics Committee. The study subjects are participating with the knowledge and approval of their general medical practitioners. This study should provide answers to the questions of who can benefit from this treatment and the ideal ways to use this patch medication to improve circulation to feet. The study will be helping the growth of understanding in this important area. This is likely to lead to improved prevention and treatment options.
Eligibility
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Interventions
Arms Assigned interventions Experimental Arm A. -"Nitro-Dur" 2.5mg daily, 24 hours, to single specified foot Experimental Arm B. - "Nitro- Dur" 1.25mg daily, 24 hours, to single specified foot Placebo Comparator Arm C. - Placebo patch daily, 24 hours to single specified foot Control Arm D. - No treatment The patches are applied once daily by the participants in the study, and the trial subject's ability to do this is checked on the first measurement visit, when they are shown how to apply the patches and their ability to do this is observed. Each subject participates for a 6 month period of daily patch treatment.
Locations(1)
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ACTRN12612000883819