Condition category
Skin and Connective Tissue Diseases
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Andrea Murray

ORCID ID

Contact details

Clinical Sciences Building
Dept. of GI Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

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 measures

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

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

http://www.srht.nhs.uk

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18077494

Publication citations

  1. 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.

Additional files

Editorial Notes