Evaluating the effectiveness of silver spray in scleroderma
Phase 2
- Conditions
- scleroderma.Systemic sclerosis [scleroderma]
- Registration Number
- IRCT20191221045837N5
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.