To determine the efficacy of silver enhanced gloves in decreasing burden of Raynaud*s phenomenon in patients with systemic sclerosis.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are the Raynaud Condition Score and the VAS
for burden caused by Raynaud*s.
Secondary outcome
Secondary endpoints include frequency and duration of Raynaud*s attacks and a
VAS for warmth of the hands as documented by the patients in a web-based log,
the degree of microangiopathy as assessed by Nailfold Capillary Microscopy
(NCM), the number of incident digital ulcers (DU) and the Scleroderma Health
Assessment Questionnaire (SHAQ).
Background summary
For over a decade, adults suffering from Raynaud*s phenomenon secondary to
systemic sclerosis, have been supplied with textiles (gloves, socks, shirts and
pants) which contain silver fibres. In general, patients state to experience
benefit from wearing these cloths. However, no substantial research has been
done to provide objective evidence supporting the hypothesis that silver fibre
enhanced textiles increase microcirculation and doing so, increase body
temperature, decrease feelings of cold and decrease complications of impaired
microcirculation including complaints of Raynaud*s phenomenon and digital
ulcers. Therefore, this study aims to evaluate the benefits of silver fibre
enhanced gloves in patients with Raynaud*s phenomenon secondary to systemic
sclerosis.
Study objective
To determine the efficacy of silver enhanced gloves in decreasing burden of
Raynaud*s phenomenon in patients with systemic sclerosis.
Study design
Double-blind, randomised, cross-over trial. The trial is designed as a cross
over trial to account for interindividual differences, weather changes during
the trial period and influences of associations of the patients related to the
colour of the gloves.
Intervention
The study will be a double-blinded study on 100 adult patients with systemic
sclerosis. All patients will wear both normal gloves and gloves containing
silver fibres, each during a period of 6 weeks. Each type of gloves will be
provided in 2 different colours. Patients will be randomised to: group I:
starting with orange gloves containing silver fibers, followed by green gloves
without silver fibers; group II: starting with orange gloves without silver
fibers, followed by green gloves with silver fibers; group 3: starting with
green gloves with silver fibers, followed by orange gloves without silver
fibers; group 4: starting with green gloves without silver fibers, followed by
orange gloves with silver fibers.
Study burden and risks
Participation in this study has several associated burdens:
- Three additional study visits will be scheduled. These will take
approximately 30-45 minutes and include completing the SHAQ, inspection of the
hands and nailfoldcapillaroscopy examination.
- Participants are requested to complete an online questionnaire three times
per week to document their complaints while wearing the gloves.
- Because the gloves used in the study will be dyed, wearing of the gloves
could cause an allergic reaction to those who have a hypersensitivity to dyeing
products.
- As the benefit of gloves containing silver threads has not been evaluated
thus far, risks directly related to the intervention are not clear. In case of
worsening of symptoms, possibly related to study gloves, participation will be
ended.
- Patients will be offered reimbursement of travel costs.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
-Age * 18 years
-Diagnosis of Systemic sclerosis according to ACR/EULAR (American College of
Rheumatology/European League Against Rheumatism) 2013 classification criteria
(total score of * 9, including a score of 3 for the RP item)
-Raynaud*s attack frequency of at least 4 attacks per week on * 3 different
days and a Raynaud Condition score (RCS) at baseline of at least 34 (on a scale
of 0-100)
-Vasoactive medication (Ca antagonists, ERA, PDE5 inhibitors) should be stable
in the 2 weeks prior to the start of the trial
-written informed consent
Exclusion criteria
- Past history of sympathectomy for Raynaud*s phenomenon
- Current treatment with iloprost, or iloprost infusion < 6 weeks prior to
screening
- Known allergy for dyes used in textiles
- Known allergy for silver fibre
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67974.058.18 |
| Other | Trial NL7904 |
| OMON | NL-OMON20637 |