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Where Art Thou O treatment for diabetic neuropathy: the sequel.

Yigit Can GuldikenAyesha MalikIoannis N PetropoulosHoda GadEinas ElgassimIuliia SalivonGeorgios PonirakisUazman AlamRayaz A Malik
Published in: Expert review of neurotherapeutics (2023)
Quantitative sensory testing, intraepidermal nerve fiber density, and especially corneal confocal microscopy remain an after-thought, demoted at best to exploratory secondary endpoints in clinical trials of diabetic neuropathy. If pharma are to be given a fighting chance to secure approval for a new therapy for diabetic neuropathy, the FDA needs to reassess the evidence rather than rely on 'opinion' for the most suitable endpoint(s) in clinical trials of diabetic neuropathy.
Keyphrases
  • clinical trial
  • wound healing
  • type diabetes
  • high resolution
  • open label
  • mass spectrometry
  • combination therapy
  • study protocol
  • replacement therapy
  • peripheral nerve