Diabetic Foot Ulcer of Neuropathic Origin Clinical Trial
Official 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
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development
code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken
Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit
consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent
for solution and a spray part to fit the glass bottle after reconstitution of the final
product.
We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group,
multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w)
and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a
superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a
maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with
placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients
will be randomized and it is planned that this study will be conducted at approximately 40
investigational sites in Europe.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01217463 -
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study
|
Phase 3 |