Clinical Trial: Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)

Brief Summary: Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage 1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The study will last for one month, for a total of 12 treatments per subject, seven subjects total, to see if there is a change in percent body fat percentage over the course of these treatments.

Detailed Summary:

Lipedema

According to an epidemiological study by Földi E and Földi M, lipedema affects 11% of the female population. Rarely, men with hypogonadism, growth hormone deficiency, or liver disease may develop lipedema. Drs. Allen and Hines from the Mayo clinic defined lipedema in 1940 and shortly thereafter provided the diagnostic criteria for lipedema:

  1. Almost exclusive occurrence in women developing by the third decade of life
  2. Bilateral and symmetrical nature with minimal involvement of the feet, resulting in an ''inverse shouldering'', ''bracelet'' or "cuff" effect at the ankle
  3. Minimal pitting edema (non-pitting edema is present)
  4. Pain, tenderness, and easy bruising
  5. Persistent enlargement despite elevation of the extremities or weight loss.
  6. Increased vascular fragility; easy bruising

There are three stages of lipedema Stage 1: Normal skin surface with enlarged hypodermis Stage 2: Uneven skin with a peau d'orange or mattress-like texture with larger mounds of tissue the size of a walnut or apple including the formation of lipomas and angiolipomas, and larger indentations in the fat Stage 3: Much larger mounds or huge lobules of tissue occurs causing deformations especially around the knees

Progression to lymphedema, called lipolymphedema (Stage 4) can develop during any Stage but most commonly occurs in people with Stage 3. Obesity can occur along with lipedema especially in Stage 3. Lifestyle improvements should always be considered for obesity associated with lipedema but lifestyle is not the caus
Sponsor: University of Arizona

Current Primary Outcome: Full Body Fat Percentage [ Time Frame: Baseline and 4 weeks ]

Change in full body fat percentage after 4 weeks of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Arizona

Dates:
Date Received: September 13, 2016
Date Started: September 2016
Date Completion: October 2016
Last Updated: September 19, 2016
Last Verified: September 2016