Tissue engineered autologous grafting versus standard care in the treatment of diabetic foot ulcers

Completed

• Conditions: Diabetic foot ulcer; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN66756247
• Lead Sponsor: Fidia Advanced Biopolymers Srl (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of healing at 12 and 20 weeks (complete healing was defined as complete re-epithelialisation of the wound).

Secondary Outcome Measures

Name	Time	Method
Evaluated at 12 weeks:<br>1. Mean healing time<br>2. Time to achieve 50% area reduction<br>3. Weekly percentage of ulcer area reduction<br><br>Registered during the entire course of the study; a specific analysis was performed at 12 weeks and at the 18 months follow-up:<br>4. Number and severity of adverse events<br><br>In order to enhance the quality of the observation, the tolerability of the treatment was observed during the treatment period and at the 18 months follow-up.