This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
University of Calgary
Calgary, Alberta, Canada
RECRUITINGDalhousie University
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGSaint Joseph Health Care Centre
London, Ontario, Canada
RECRUITINGEfficacy - Number (%) of healed baseline ulcers
Number (%) of healed baseline ulcers and change in net ulcer burden
Time frame: Screening, Day 1, Day 28, Day 56
Safety - number of adverse events
The number of product related adverse events experienced
Time frame: Screening, Day 1, Day 28, Day 56
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The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGMount Sinai Health System
Toronto, Ontario, Canada
RECRUITING