Scleroderma, Systemic, Digital Ulcer
Conditions
Keywords
SSc, Digital Ulcers, Sclerosis, Scleroderma
Brief summary
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_PRODUCTDiosmin
A medical food of diosmin and alka4-complex
OTHERPlacebo
Corn starch one (1) capsule twice daily
Sponsors
KGK Science Inc.
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All subjects de-identified, all study staff blinded, all product labeled with number assignment, randomization performed by computer, number assignment conveyed to blinded study staff via computer.
Intervention model description
This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Number (%) of healed baseline ulcers | Screening, Day 1, Day 28, Day 56 | Number (%) of healed baseline ulcers and change in net ulcer burden |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - number of adverse events | Screening, Day 1, Day 28, Day 56 | The number of product related adverse events experienced |
Countries
Canada
Contacts
Primary ContactLukban
Backup ContactMary L Sanstead
Outcome results
None listed