ISRCTN66756247
Completed
Not Applicable
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 sites200 target enrollmentAugust 11, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic foot ulcer
- Sponsor
- Fidia Advanced Biopolymers Srl (Italy)
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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