Iontophoresis as a possible therapy for digital ischaemia
| ISRCTN | ISRCTN84211155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84211155 |
| Secondary identifying numbers | 6621 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 29/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Andrea Murray
Scientific
Scientific
Clinical Sciences Building
Dept. of GI Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
| Study design | Single centre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Tonia.Moore@srft.nhs.uk to request a patient information sheet |
| Scientific title | Iontophoresis as a possible therapy for digital ischaemia - preliminary studies in patients with scleroderma spectrum disorders |
| Study acronym | Iontophoresis Study |
| Study objectives | 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(s) | Salford and Trafford Research Ethics Committee approved (ref: 04/Q1404/209) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2006 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 6; UK sample size: 6 |
| Key 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 |
| Key exclusion criteria | 1. Aged less than 18 or greater than 80 years 2. Pregnancy |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Sciences Building
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Rheumatic Diseases Centre, CSB
Hope Hospital
Stott Lane
Salford
M6 8HD
England
United Kingdom
| Website | http://www.srht.nhs.uk |
|---|---|
"ROR" |
https://ror.org/019j78370 |
Funders
Funder type
Research organisation
Raynaud's and Scleroderma Association (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2008 | Yes | No |
