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Your journey
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More info
You can access this
clinical trial
if you have
Diabetes Mellitus or Diabetic Neuropathic Foot Ulcer
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe

Provided treatments

  • Device: SANIDIAB
  • Device: BAROUK

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01586481. The sponsor of the trial is Assistance Publique - Hôpitaux de Paris and it is looking for 33 volunteers for the current phase.
Official trial title:
Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study