Study of Diosmin-Diosmetin for the Treatment of Digital Ulcers in Systemic Sclerosis

February 24, 2024 updated by: Primus Pharmaceuticals

Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin-Diosmetin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study

This study is performed to consider the safety and healing ability of diosmin-diosmetin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). . The study will include 21-45 patients who will randomly be given either active product or inactive product (placebo). Two (2) out of every three (3) patients enrolled will receive active product. The patients 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.

Diosmin-Diosmetin is a naturally occurring compound found in citrus fruits and vegetables known as flavonoids. This product has been used to treat poor blood circulation in a variety of countries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
diosmin xxx mg, plus diosmetin xxx mg, one (1) capsule, two (2) times per day for eight (8) weeks
Combination product: Diosmin plus Diosmetin
diosmin plus diosmetin one (1) capsule twice daily
Placebo Comparator: Placebo
cornstarch, xxx mg, one (1) capsule, two (2) times per day for eight (8)
Drug: Corn starch
Corn starch one (1) capsule twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Incidence, relationship, and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline to Visit 4 at Week 8
Incidence, relationship, and severity of adverse events (AEs) and serious adverse events (SAEs)
Baseline to Visit 4 at Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Number (%) of healed baseline ulcers
Time Frame: Screening to Visit 4 at 8 weeks
Number (%) of healed baseline ulcers Number (%) of participants with at least one healed baseline ulcer Number (%) of healed baseline "cardinal" ulcers Number (%) of ulcers exhibiting > 50% healing Change in Net Ulcer Burden
Screening to Visit 4 at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primus Pharmaceuticals

Collaborators

KGK Science Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVDUS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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