Evaluation of the efficacy and safety of autologous grafts of fibroblasts and keratinocytes grown on scaffolds composed of HYAFF 11, a derivative of hyaluronic acid, in the treatment of diabetic foot ulcers: a randomised, controlled, multicentre trial

Fidia Advanced Biopolymers Srl (Italy)0 个研究点目标入组 200 人开始时间: 2009年8月11日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patient with diabetes type 1 or 2, with ulcer located on plantar or dorsal site, with an area greater than 2 cm^2
•2. Male or female greater than or equal to 18 years old
•3. Non-fertile female or fertile females, who use oral contraceptives or intrauterine devices and with a negative pregnancy test
•4. Ulcer with Wagner score 1 - 2
•5. Patients with transcutaneous partial pressure of oxygen (TcPO2) greater than or equal to 20 mmHg
•6. Ulcers without tendency to heal for at least 1 month
•7. Ankle branchial index greater than or equal to 0.5

•1. Patients who did not give written informed consent
•2. Patients with osteomylitis
•3. Ulcers with positive bacteriological swabs
•4. Patients for whom the use of off-loading device is not recommended
•5. Patients who have a re-vascularisation from less than 30 days
•6. Patients with serious liver and/or renal insufficiency
•7. Patients with malignant neoplasm or diseases with unfavourable prognosis
•8. Patients in treatment with corticosteriods, immunosuppressants and/or cytostatic drugs
•9. Pregnancy or suspected pregnancy
•10. Participation on another clinical trial in foot ulcer treatment during the last two weeks
•Only for patients assigned to the treatment group (tissue engineered autografts):
•11. Patients who refuse to undergo, prior to study initiation, the following tests: 11.1. Hepatitis B surface antigens (HBsAg)
•11.2. Hepatitis C virus (HCV)
•11.3. Anti-human immunodeficiency virus 1 (Anti-HIV 1)
•11.4. Anti-human immunodeficiency virus 2 (Anti-HIV 2)

发起方

Fidia Advanced Biopolymers Srl (Italy)