Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional

Summary: 
      Diosmiplex is a product marketed for the management of diseases due to venous and
      microvascular dysfunction. Raynaud's phenomenon is a disorder of characterized by spasm of
      small arteries and impaired microvascular flow. This study will examine the effects of
      diosmiplex on the frequency and severity of Raynaud's episodes in susceptible people.
    

Detailed description: 
      Raynaud's phenomenon is a disorder characterized by spasm of digital arteries leading to
      blanching, coldness and discomfort of the affected digit, affecting up to 3-5% of the
      population at some time in their lives. Raynaud's is roughly classified into primary and
      secondary forms. The primary form may occur without apparent cause or following such things
      as acute trauma, repetitive vibrating trauma or frostbite. Secondary Raynaud's occurs in
      association with a variety of systemic immunological diseases such as rheumatoid arthritis
      (RA), systemic lupus erythematosus (SLE), systemic sclerosis (SS) and Sjogren's syndrome.
      Perhaps the most severe forms are associated with systemic sclerosis, less often in SLE where
      severe microvascular changes can lead to digital ulcerations which are difficult to heal and
      produce considerable functional impairment Treatment of Raynaud's has been a significant
      clinical challenge. The primary modality is to avoid cold exposure. Many drug classes have
      been shown to have some, but highly variable and potential toxicities.

      Diosmiplex is a prescription medical food product composed of the botanical based flavonoid
      molecule, diosmin, and a proprietary systemic blood alkalinizing agent, Alka4-complex.
      Diosmin has been used successfully in Europe as a drug for chronic venous insufficiency and
      its complications, including venous ulcers for more than 35 years. There is a large body of
      published literature regarding the molecular activity, clinical efficacy and safety of the
      active molecule in diosmin as well as its effects on the microvasculature where it has been
      shown to reduce inflammation, improve structural integrity, reduce capillary damage and
      improve capillary flow but no prospective clinical studies have been published regarding its
      effect in Raynaud's phenomenon. This will be the first prospective study to examine the
      efficacy and safety of diosmin, as diosmiplex, in both primary and secondary Raynaud's. The
      study will intentionally seek to enroll a subset of subjects with scleroderma with Raynaud's
      complicated by digital ulcers.

      This will be a two (2) month randomized, double blind, placebo controlled study. Patients
      with either primary or secondary Raynaud's phenomenon present for at least 12 months and
      either untreated or inadequately controlled on therapy, defined as having at least four (4)
      vasospastic episodes/week, will be eligible for enrollment
    

Intervention name(s): placebo; diosmiplex
Intervention type(s): Other; Dietary Supplement
Intervention description(s): inactive placebo; diosmiplex is an FDA regulated medical food product
Other intervention name(s): Vasculera
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention