Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6621
Study information
Scientific title
Iontophoresis as a possible therapy for digital ischaemia - preliminary studies in patients with scleroderma spectrum disorders
Acronym
Iontophoresis Study
Study hypothesis
Six patients with scleroderma (SSc) spectrum disorder, and associated digital ischaemia and/or ulceration, who are in hospital to receive intravenous (IV) vasodilation therapy, will be recruited for the study.
Ethics approval
Salford and Trafford Research Ethics Committee approved (ref: 04/Q1404/209)
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Tonia.Moore@srft.nhs.uk to request a patient information sheet
Condition
Topic: Skin, Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics), Skin (all Subtopics); Disease: Musculoskeletal, Dermatology
Intervention
Iontophoresis will be delivered over the whole finger. The iontophoresis dose will be 200 uA of 0.5% NaNP (diluted by volume in distilled water) for 5 mins, 4 times a day (but this will be reduced if troublesome tingling/paraesthesis occurs with this schedule) for 5 days (the duration of the iloprost treatment). The NaNP iontophoresis will be ADDITIONAL to the IV prostanoid therapy for which the patient was admitted.
Follow-up length: 0 months
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Increase in perfusion; one laser Doppler image will be taken before and after treatment on days 1, 2 and 5 where possible.
Secondary outcome measures
1. Modified Scleroderma Health Assessment Questionnaire (SHAQ); these will be filled out by patients at the start and end of the 5 day treatment period
2. Patient opinion, measured at the end of the 5 day treatment period
Overall trial start date
01/09/2006
Overall trial end date
30/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A diagnosis of SSc (or of another scleroderma-spectrum disorder)
2. Severe digital ischaemia
3. Digital ulceration severe enough to require hospitalisation for intravenous prostanoid therapy
4. Aged 18 - 80 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 6; UK sample size: 6
Participant exclusion criteria
1. Aged less than 18 or greater than 80 years
2. Pregnancy
Recruitment start date
01/09/2006
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Sciences Building
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
Rheumatic Diseases Centre
CSB
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Raynaud's and Scleroderma Association (UK)
Alternative name(s)
RSA
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18077494
Publication citations
-
Results
Murray AK, Moore TL, King TA, Herrick AL, Vasodilator iontophoresis a possible new therapy for digital ischaemia in systemic sclerosis?, Rheumatology (Oxford), 2008, 47, 1, 76-79, doi: 10.1093/rheumatology/kem314.