Effectiveness of glyceryl trinitrate patches on vascular perfusion and pain in ischaemic feet: a randomised controlled trial

Charles Sturt University0 个研究点目标入组 100 人开始时间: 2012年8月20日最近更新: 2020年1月13日

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•Inclusion Criteria
•Able to speak and comprehend spoken English
•Aged 18 or over
•Willing and able to give informed consent to the elements of the study
•Willing and able to comply with the commitments of the study including
•-using a patch on one foot for 6 months and replacing this patch daily (carers are able to assist with this if necessary)
•- attending for one assessment and 7 measurement visits over 6 months (more visits are required if wounds are present)
•-active drug participants will be required to have a single blood test to measure the amount of medication they have absorbed
•A toe pressure (TP) of a systolic BP of<80 mmHg OR a toe pressure index (TPI) of <0.65 on either side is the threshold for inclusion due to significant vascular impairment
•Other toes can be used for the measurements if either one or both of the big toes are missing. The presence of at least one toe on each foot is required.

•Exclusion Criteria
•Unable to communicate in spoken English
•Disabling psychiatric conditions including Dementia
•Leg wounds above the ankle without adequate compression therapy in place-
•Currently using glyceryl trinitrate in any form. This includes patches and spray for use under the tongue as treatment for angina
•Using Sildenafil (Viagra), Tildenafil (Cilalis) or Vardenafil (Levitra)
•Very high blood pressure-Uncontrolled hypertension of >160 mmHg systolic or >110 mmHg diastolic pressure readings
•Very low blood pressure -Brachial hypotension of < 100 mmHg systolic
•Heart failure associated with the following causes- Myocardial insufficiency due to obstruction, Hypertrophic Cardiomyopathy, Aortic or Mitral Stenosis, Pericarditis
•Increased intracranial or intraocular pressure- Glaucoma
•Marked Anaemia
•History of allergy to glyceryl trinitrate or patch adhesives or patch components
•Hot spots”- on either foot which exceed 4 degrees in temperature relative to the rest of the foot or the opposite foot.

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