Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrimus Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of systemic sclerosis (scleroderma)
At least one "active" digital ulcer
Medication for systemic sclerosis unchanged for 30 days
Disqualifiers
Infection or gangrene in ulcer
Citrus allergy
Unstable heart, kidney, or liver disease
Active infection of any type
Trial design
Design model
Parallel
Treatments tested in this trial
Diosmin
Combination productA medical food of diosmin and alka4-complex
Placebo
Other interventionCorn starch one (1) capsule twice daily
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy - Number (%) of healed baseline ulcers
Number (%) of healed baseline ulcers and change in net ulcer burden
Time frame
Screening, Day 1, Day 28, Day 56Secondary outcomes
1
Safety - number of adverse events
The number of product related adverse events experienced
Time frame
Screening, Day 1, Day 28, Day 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Primus Pharmaceuticals
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov