Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diosmin, Placebo.
- Who it may be relevant to
- Registry conditions: Scleroderma, Systemic, Digital Ulcer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Combination product Diosmin
A medical food of diosmin and alka4-complex - Other Placebo
Corn starch one (1) capsule twice daily
Primary outcome measures
- Efficacy - Number (%) of healed baseline ulcers [Time frame: Screening, Day 1, Day 28, Day 56]
Secondary outcome measures (1)
- Safety - number of adverse events [Time frame: Screening, Day 1, Day 28, Day 56]
Eligibility criteria
Inclusion criteria
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
Exclusion criteria
- Infection or gangrene in ulcer
- Citrus allergy
- Unstable heart, kidney, or liver disease
- Active infection of any type
- Current cancer treatment or uncured cancer
- Pregnancy or breast feeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 5 centers
- University of Calgary — Calgary
- Dalhousie University — Halifax
- Saint Joseph Health Care Centre — London
- The Ottawa Hospital — Ottawa
- Mount Sinai Health System — Toronto
Identifiers
NCT: NCT06256575 · PVDUS-01