Innocoll Pharmacoeconomic Study

• Research type

  Research Study

• Full title

  A European Piggy-backed Economic Study of the Cost and Resource Utilization of a Topical Gentamicin-Collagen Sponge in Diabetic Patients with an Infected Foot Ulcer

• IRAS ID

  188015

• Contact name

  Lisa Hemsen

• Contact email

  lhemsen@innocollinc.com

• Sponsor organisation

  Innocol Pharmaceuticals Limited

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  Infected Diabetic foot ulcers (iDFU) are a serious problem both clinically and financially for healthcare authorities as the infection causes the treatment of the wound to be prolonged. If the infection cannot be successfully treated, it may lead to hospitalisation for more intensive treatment, or amputation.
  Standard treatments for iDFU are debridement and antibiotic medication, given as tablets or injections, such as gentamicin sulphate. Antibiotics like this can have many side effects and toxicities associated with them.
  Innocoll have developed Cogenzia, a collagen sponge, impregnated with the antibiotic gentamicin sulphate, which can be applied directly to the iDFU, thereby reducing the toxicities associated with taking tablets or injections. This is currently in Phase 3 trials compared to a placebo sponge and to standard of care in people with moderately or severely iDFU (INN-TOP-005)
  To be able to demonstrate that Cogenzia is a cost effective treatment in terms of the healthcare authorities perspective, Innocoll have sponsored this economic study on the back of INN-TOP-005 clinical study. This study will collect various information such as the number of visits the participants will make to clinics, and other healthcare services that may be used, effectiveness data will come from the clinical study INN-TOP-005, along with event probabilities such as infection cures, ulcers healed, hospitalisations and amputations.
  This study will take place in Europe and the UK and will include all investigative sites and trial patients in all the above countries that are willing to participate. Approximately 500 participants are expected to take part in this study

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  15/EM/0421

• Date of REC Opinion

  4 Sep 2015

• REC opinion

  Favourable Opinion