INN-TOP-005- Gentamicin- Collagen Sponge in Diabetic Foot Ulcers

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

• IRAS ID

  180267

• Contact name

  Lisa Hemsen

• Contact email

  lhemsen@innocollinc.com

• Sponsor organisation

  Innocoll Pharmaceuticals Limited

• Eudract number

  2015-000934-31

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  Foot ulcers, where an area of the skin has broken down to display the underlying tissue, are a common occurrence in people with Diabetes. High sugar levels in the blood over time in diabetic patients causes damage to the nerves resulting in reduced sensation on the skin of the feet.
  People with diabetes also have an increased risk of developing narrowing of the arteries. This causes poor circulation to the feet, leading to skin not healing properly and being more likely to become damaged. Both these conditions make the foot prone to infection and ulcers, which are a leading cause of limb amputations in people with diabetes
  Current treatments involve evaluation of infection, surgical removal of dead tissue, and either oral or intravenous antibiotic therapy.
  Gentamicin sulphate is widely approved antibiotic in the treatment of foot ulcers.
  Innocol Pharmaceuticals LTD, have developed a gentamicin-sponge consisting of highly purified collagen (a fibrous substance derived from a beef source) matrix containing gentamicin sulphate. When applied directly to the skin, the sponge has been developed to provide a high local concentration of gentamicin without causing high concentrations throughout the rest of the body, thereby significantly reducing the risk of kidney and ear damage commonly associated with this antibiotic.
  Approximately 500 patients with diabetes mellitus with at least one infected foot ulcer will be assigned randomly to the following groups:

  Systemic antibiotic therapy and standard ulcer care with either:
  A) Daily application of a gentamicin sponge
  B) Daily application of a placebo sponge
  C) No-sponge

  Patients will have 2 in 3 chance of receiving the study drug.

  This a is randomised controlled blinded study which means that the investigator will not know which treatment the patients are receiving, and the patients will not know whether they are receiving the study drug or the placebo (a drug that has no medical effect).

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  15/EM/0294

• Date of REC Opinion

  23 Jul 2015

• REC opinion

  Further Information Favourable Opinion