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Evaluating the effectiveness of silver spray in scleroderma

Evaluating the effectiveness of nano silver spray on digital ulcers of patients with scleroderma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191221045837N5
Enrollment
50
Registered
2023-09-09
Start date
2023-12-22
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

scleroderma. Systemic sclerosis [scleroderma]

Interventions

Intervention 1: Intervention group: In the intervention group, patients use silver nanospray 4 times a day (every 6 hours) on the finger ulcers. Intervention 2: Control group: In the control group, pa

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged > 18 years 2. Patients with finger ulcers, caused by scleroderma, with mild to moderate severity (1-10 new ulcers in the fingers involving surface epithelial cells, the epidermis, the dermis, or the subcutaneous tissue) and without purulent discharge 3. Patients who signed our patient consent permission form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe finger ulcers (more than 10 new ulcers in the fingers, extensive tissue destruction with damage to muscle, supporting structures (eg, tendon, joint capsule) and bone, necrosis and gangrene) Patients who do not use the spray regularly

Design outcomes

Primary

MeasureTime frame
The size of ulcers. Timepoint: weekly. Method of measurement: Length x Width: Measure the greatest length (head to toe) and the greatest width (side to side) using a centimeter ruler.;(DUS) digital ulcer score. Timepoint: weekly. Method of measurement: Length x depth of ulcer.;The healing time of ulcers. Timepoint: weekly. Method of measurement: Observing the appearance of the ulcer.

Secondary

MeasureTime frame
Intensity of pain in patients with ulcers. Timepoint: weekly. Method of measurement: visual analogue scale (VAS).;The quality of life of patients. Timepoint: weekly. Method of measurement: Health-Related Quality of Life (HRQOL) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZinat Heidari

Mashhad University of Medical Sciences

heidarizn@mums.ac.ir+98 51 3180 1584

Outcome results

None listed

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