C3206 V3

• Research type

  Research Study

• Full title

  Prospective, multicenter, parallel, open-label, randomized, controlled trial to investigate the ability of Cutimed Sorbact to decrease the risk of infections in patients with non-infected diabetic foot ulcers compared to standard of care.

• IRAS ID

  347528

• Contact name

  Paul Chadwick

• Contact email

  paul.chad@live.co.uk

• Sponsor organisation

  BSN Medical GmbH

• Duration of Study in the UK

  1 years, 9 months, 29 days

• Research summary

  The aim of this study is to assess the use of Sorbact gel dressing or swabs in addition to standard of care in preventing infection in diabetic foot ulcers. The devices will be used within their intended use. Patients will be randomised to receive either Standard of Care or SOC in conjunction with the Sorbact dressings or gel. Study participation is expected to last 12 weeks. This study will take place in approximately 30 sites across the UK.
  The investigational devices to be used in this clinical investigation are Cutimed® Sorbact® Swab and Cutimed® Sorbact® Gel. The dressings bind bacteria and fungi through the hydrophobic Sorbact® surface. The fabric of the dressings is impregnated with dialkylcarbamoyl chloride (DACC), and its hydrophobic properties facilitate the binding of common wound microbes to it.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  24/LO/0889

• Date of REC Opinion

  31 Jan 2025

• REC opinion

  Further Information Favourable Opinion