Effectiveness of glyceryl trinitrate patches for people with impaired circulation in their feet: a randomised controlled trial

Phase 3

Recruiting

• Conditions: Peripheral arterial disease of the feet; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12612000883819
• Lead Sponsor: Charles Sturt University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified