Iontophoresis as a possible therapy for digital ischaemia
| ISRCTN | ISRCTN84211155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84211155 |
| Protocol serial number | 6621 |
| Sponsor | Salford Royal NHS Foundation Trust (UK) |
| Funder | Raynaud's and Scleroderma Association (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Increase in perfusion; one laser Doppler image will be taken before and after treatment on days 1, 2 and 5 where possible. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Clinical Sciences Building
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
