Iontophoresis as a possible therapy for digital ischaemia - preliminary studies in patients with scleroderma spectrum disorders - Vasodilator iontophoresis as a possible therapy for digital ischaemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002799-41-GB

Enrollment

Registered

2005-06-29

Start date

2007-08-15

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digital ischaemia/ulceration in patients with scleroderma-spectrum disorders

Interventions

Trade Name: NON PROPIETRY, THEREFORE N/A Product Name: SODIUM NITROPRUSSIDE Pharmaceutical Form: Powder for injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A diagnosis of SSc (or of another scleroderma-spectrum disorder) and severe digital ischaemia and/or digital ulceration severe enough to require hospitalisation for intravenous prostanoid therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age 80 years. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: This study follows on from a project entitled 'Iontophoresis as a possible therapy for digital ischaemia, preliminary studies in healthy volunteers'. The aim of the new study is to determine whether iontophoresis (a method of driving drugs or chemicals through the skin with very low currents) of vasodilatory chemicals (chemicals that temporarily widen the blood vessels, allowing higher blood flow) improves the healing rate of ulcers on the finger and/or improves digital ischaemia severe enough to require hospitalisation for intravenous vasodilator therapy. The desired outcome is that this novel method of vasodilatory delivery reduces the required treatment time and therefore the hospitalisation time of the patients. If so then this therapy might, in the future, replace intravenous prostanoid therapy. It should be stated that what is proposed are preliminary studies which will not definitely answer these questions but will inform future controlled clinical trials. ;Secondary Objective: ;Primary end point(s): The primary endpoint will be an increase in perfusion as imaged by dual wavelength laser Doppler imaging, in which we have extensive experience. One laser Doppler image of the affected area will be taken before and after treatment on days 1, 2 and 5 where possible.	—

Measure

Time frame

Main Objective: This study follows on from a project entitled 'Iontophoresis as a possible therapy for digital ischaemia, preliminary studies in healthy volunteers'. The aim of the new study is to determine whether iontophoresis (a method of driving drugs or chemicals through the skin with very low currents) of vasodilatory chemicals (chemicals that temporarily widen the blood vessels, allowing higher blood flow) improves the healing rate of ulcers on the finger and/or improves digital ischaemia severe enough to require hospitalisation for intravenous vasodilator therapy. The desired outcome is that this novel method of vasodilatory delivery reduces the required treatment time and therefore the hospitalisation time of the patients. If so then this therapy might, in the future, replace intravenous prostanoid therapy. It should be stated that what is proposed are preliminary studies which will not definitely answer these questions but will inform future controlled clinical trials. ;Secondary Objective: ;Primary end point(s): The primary endpoint will be an increase in perfusion as imaged by dual wavelength laser Doppler imaging, in which we have extensive experience. One laser Doppler image of the affected area will be taken before and after treatment on days 1, 2 and 5 where possible.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026