Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000883819
Ethics application status
Approved
Date submitted
12/07/2012
Date registered
20/08/2012
Date last updated
27/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of glyceryl trinitrate patches for people with impaired circulation in their feet: a randomised controlled trial
Scientific title
Effectiveness of glyceryl trinitrate patches on vascular perfusion and pain in ischaemic feet: a randomised controlled trial
Secondary ID [1] 281046 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral arterial disease of the feet 286856 0
Condition category
Condition code
Cardiovascular 287179 287179 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285225 0
Treatment: Drugs
Comparator / control treatment
Placebo Arm C.
Placebo patch is visually almost identical to 1.25 mg "Nitro- Dur" patch using the same adhesive but with no drug content.
Control Arm D.
No treatment but monthly monitoring as for all study arms
Control group
Placebo

Outcomes
Primary outcome [1] 287474 0
1. Vascular Toe pressure at the hallux (big toe) as measured by automated photoplethysmography
Timepoint [1] 287474 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period.
Primary outcome [2] 287475 0
2. Pain experience as measured by Visual Analogue Pain Scale ruler tool
Timepoint [2] 287475 0
Timepoint - At baseline and at month 6 of the study monitoring period.
Secondary outcome [1] 298241 0
Quality of Life Score , as measured by validated short scale
Timepoint [1] 298241 0
Timepoint - At baseline and at months 1,3, 6 of study monitoring period.
Secondary outcome [2] 298242 0
Sensory light touch indicative of protective sensation, as measured with 10 g Semmes-weinstien monofilament
Timepoint [2] 298242 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [3] 298243 0
Position sense- manual clinical test
Timepoint [3] 298243 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [4] 298244 0
Temperature discrimination as measured by the Twin-tip thermal discriminator tool and test protocol
Timepoint [4] 298244 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [5] 298245 0
Brachial Systolic Blood pressure as measured by Desktop sphygmomanometer
Timepoint [5] 298245 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [6] 298246 0
Pulse palpation of Tibialis Anterior pulses
Timepoint [6] 298246 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [7] 298247 0
Doppler testing of Tibialis Anterior pulses
Timepoint [7] 298247 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [8] 298248 0
Skin temperatures of Hallux apex, 1st metatarsophalangeal joint (MPJ), midfoot, with skin thermometer
Timepoint [8] 298248 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [9] 298249 0
temperatures of test room, min and max daily temperatures of measurement days
Timepoint [9] 298249 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [10] 298250 0
number of wounds present and rating of any wounds using wound rating scale
Timepoint [10] 298250 0
Timepoint - At baseline and at months 1,2,3,4,5,6 of study monitoring period
Secondary outcome [11] 298251 0
Vibration sense, as measured by Vibration Sensory Analyser tool
Timepoint [11] 298251 0
Timepoint - At baseline and at months 4,6 of study monitoring period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. All study subjects who have met the inclusion criteria are allocated a sequential study number.

2. Numbered envelopes are prepared with the study subject's numbers on the outsides of the envelopes

3. This study contains 4 treatment groups. They are as follows;-
1. High dose
2. Low dose
3. Placebo and
4. Control

4. Small paper chits, with the group numbers 1-4 are prepared in quantity adequate for the number of eligible subjects at each intake.

5. An intermediary person, not involved with the study will place these previously numbered chits in to the numbered envelopes in accordance with a random order.
This random number sequence is provided by the statistician involved with the study using Fisher's random number tables.

6. To achieve balance in the numbers of participants per group, the numbers 1 to 4 will be randomised in sets of four, and allocated to groups of four consecutively-numbered envelopes according to the randomised order. A separate randomisation is used for each group of four envelopes.

7. A witnessed scrutineer, independent of the study will then open the envelopes and record the allocated group for each study participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This random number sequence is provided by the statistician involved with the study sourced from Fisher's Random Number Tables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285588 0
University
Name [1] 285588 0
School of Biomedical Sciences Compact Funds Scholarship
Country [1] 285588 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Charles Sturt University
Research Office
Locked Bag 588
Wagga Wagga
NSW 2650
Country
Australia
Secondary sponsor category [1] 284618 0
None
Name [1] 284618 0
Address [1] 284618 0
Country [1] 284618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287595 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 287595 0
Office of Academic Governance
Private Mail Bag 29
Panorama Ave
Bathurst
NSW 2795
Ethics committee country [1] 287595 0
Australia
Date submitted for ethics approval [1] 287595 0
16/06/2011
Approval date [1] 287595 0
08/11/2011
Ethics approval number [1] 287595 0
2011/146

Summary
Brief 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.
Trial website
Trial related presentations / publications
Poster presentation:

Glyceryl trinitrate patch therapy is associated with healing of arterial ulceration and improvement in toe pressure measurements: a case study and discussion of aspects of this novel treatment modality. Sylvia McAra, Journal of Foot and Ankle Research 2011, 4(Suppl 1):P36 http://www.jfootankleres.com/content/4/S1/P36. From Australasian Podiatry Council Conference 2011 Melbourne, Australia. 26-29 April 2011

Oral presentation:

Glyceryl trinitrate therapy for ischaemia, painful diabetic neuropathy, healing of foot ulceration and other podiatric conditions: a literature review. Sylvia McAra, Journal of Foot and Ankle Research 2011, 4(Suppl 1):O28 http://www.jfootankleres.com/content/4/S1/O28. From Australasian Podiatry Council Conference 2011 Melbourne, Australia. 26-29 April 2011
Public notes

Contacts
Principal investigator
Name 34408 0
Address 34408 0
Country 34408 0
Phone 34408 0
Fax 34408 0
Email 34408 0
Contact person for public queries
Name 17655 0
Sylvia McAra
Address 17655 0
Allied Health Clinic
Charles Sturt University
PO Box 789 Albury
2640
NSW
Country 17655 0
Australia
Phone 17655 0
+61 2 60519299
Fax 17655 0
+61 2 60519299
Email 17655 0
[email protected]
Contact person for scientific queries
Name 8583 0
Sylvia McAra
Address 8583 0
Allied Health Clinic
Charles Sturt University
PO Box 789 Albury
2640
NSW
Country 8583 0
Australia
Phone 8583 0
+61 2 60519299
Fax 8583 0
+61 2 60519299
Email 8583 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTemporal (in)stability of suboptimal toe-brachial indices.2018https://dx.doi.org/10.1016/j.foot.2018.03.001
N.B. These documents automatically identified may not have been verified by the study sponsor.