Clinical Trial: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Treatment of Metatarsalgia of Forefeet Further Use of High Heel Shoes

Brief Summary: Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes

Detailed Summary: This will be an open and single center study. There will be 4 study visits in total for each subject. Each subject will participate for a period of maximum 6 months.
Sponsor: Galderma

Current Primary Outcome:

  • Pain assessment (Time to onset of pain (TInitial) (in hours) [ Time Frame: Subject questioning at baseline after injections and change from baseline 1 month after baseline ]
    Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations
  • Pain assessment (Time to maximum pain tolerance (TEnd) [ Time Frame: Subject questioning at baseline after injections and change from baseline 1 month after baseline ]
    (in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Podiatric criteria [ Time Frame: Change from baseline 6 months after baseline ]

    Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure:

    - Mean pressure under metatarsal heads

  • Podiatric criteria (Baro Podometric static examinations) [ Time Frame: Change from baseline 6 months after baseline ]

    Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure:

    - Maximum mean pressure under metatarsal heads



Original Secondary Outcome: Same as current

Information By: Galderma

Dates:
Date Received: December 9, 2014
Date Started: November 2014
Date Completion:
Last Updated: November 9, 2015
Last Verified: November 2015