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

ISRCTN	ISRCTN66756247
DOI	https://doi.org/10.1186/ISRCTN66756247
Secondary identifying numbers	CT/240/248/98-03

Submission date: 24/06/2009
Registration date: 11/08/2009
Last edited: 11/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Doriana Senigaglia
Scientific

Via Ponte della Fabbrica 3/B
Abano Terme - Padova
35031
Italy

Study information

Study design	Randomised controlled multicentre clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Doriana Senigaglia at dsenigaglia@fidiapharma.it to request a patient information sheet
Scientific title	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
Study objectives	The study compared the efficacy and adverse event profile of autologous tissue engineered grafts (Hyalograft 3D™ autograft and Laserskin® autograft) versus standard care (paraffin gauze) in the local treatment of diabetic foot ulcers.
Ethics approval(s)	Ethics Committee of the Università Cattolica del Sacro Cuore - Facoltà di Medicina e Chirurgia (Agostino Gemelli) approved on the 22nd February 1999 (ref: Prot.Dg P37/C.E. [A. 48]). The study received the favourable opinion by the Ethic Committees of all the 7 centres involved. All other centres will seek ethics approval before recruiting participants.
Health condition(s) or problem(s) studied	Diabetic foot ulcer
Intervention	The study protocol provided a first treatment phase with the grafting of Hyalograft 3D™ autograft (autologous graft of fibroblasts grown on a HYAFF scaffold) followed, a fortnight later, by the grafting of Laserskin® autograft (autologous graft of keratinocytes grwon on a HYAFF scaffold). Single or double grafts of each products were allowed at the investigator's discretion. The control group was treated with the paraffin gauze Jelonet on direct contact with the wound. All the patients used an appropriate off-loading device (plantar ulcers) or therapeutic shoes (dorsal ulcers).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hyalograft 3D™ autograft, Laserskin® autograft
Primary outcome measure	Rate of healing at 12 and 20 weeks (complete healing was defined as complete re-epithelialisation of the wound).
Secondary outcome measures	Evaluated at 12 weeks: 1. Mean healing time 2. Time to achieve 50% area reduction 3. Weekly percentage of ulcer area reduction Registered during the entire course of the study; a specific analysis was performed at 12 weeks and at the 18 months follow-up: 4. Number and severity of adverse events 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.
Overall study start date	15/09/1999
Completion date	17/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 (100 patients for each arm)
Key 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
Key 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)
Date of first enrolment	15/09/1999
Date of final enrolment	17/01/2006

Locations

Countries of recruitment

Italy

Study participating centre

Via Ponte della Fabbrica 3/B

Abano Terme - Padova
35031
Italy

Sponsor information

Fidia Advanced Biopolymers Srl (Italy)
Industry

Via Ponte della Fabbrica 3/B
Abano Terme
35031
Italy

Website	http://www.fidiapharma.com
"ROR"	https://ror.org/00dy5wm60

Funders

Funder type

Industry

Fidia Advanced Biopolymers Srl (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan