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
Inclusion Criteria9
- 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 Criteria12
- 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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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