TRANS North (TRAfermin in Neuropathic diabetic foot ulcer Study)

• Research type

  Research Study

• Full title

  A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment with Trafermin 0.01% Spray in Patients with Diabetic Foot Ulcer of Neuropathic Origin The TRAfermin in Neuropathic diabetic foot ulcer Study - Northern Europe The TRANS-North study

• IRAS ID

  59060

• Contact name

  Michael Edmonds

• Sponsor organisation

  Olympus France SAS

• Eudract number

  2010-021015-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This controlled study is designed to ask whether Trafermin 0.01% Spray which is a growth factor improves healing of Diabetic Foot Ulcers (DFU) when compared with placebo/dummy/non-active treatment. Neuropathy (sensory nerve damage & loss of sensation) due to prolonged elevated blood glucose reduces patients' awareness of pressure damage to their feet, so their risk of DFU is high; a serious complication occurring in up to 25% of diabetics. DFU are difficult wounds to heal and are treated with pressure-relieving (off-loading) shoes and dressings. Research into wound healing has identified a range of naturally occurring factors which speed up the repair of tissue. Pharmaceutically produced copies of such factors have been developed and Trafermin is one type, produced by altered bacteria. Trafermin is a specific growth factor which stimulates the activity of fibroblasts (type of cell involved in tissue repair). Participants will receive Trafermin/placebo as a daily spray to the DFU for 12 weeks or less if wound heals sooner, along with normal care. Participants will have 40 further weeks of follow-up care and assessment. Participants will be over 18, male or female with non-infected DFU recruited at diabetic foot clinics which they would be attending for specialist foot care. Wound healing rates will be compared between treatment groups. Also area, depth and colour of the DFU will be assessed plus photography and rate of wound re-opening. Participant safety will be monitored throughout with routine blood tests & assessment of adverse events. Secondary parameters such as amputation, DFU recurrence & infection rates will also be measured.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/54

• Date of REC Opinion

  30 Sep 2010

• REC opinion

  Further Information Favourable Opinion