Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT/240/248/98-03
Study information
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
Acronym
Study hypothesis
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
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.
Study design
Randomised controlled multicentre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Doriana Senigaglia at dsenigaglia@fidiapharma.it to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/09/1999
Overall trial end date
17/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 (100 patients for each arm)
Participant 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)
Recruitment start date
15/09/1999
Recruitment end date
17/01/2006
Locations
Countries of recruitment
Italy
Trial participating centre
Via Ponte della Fabbrica 3/B
Abano Terme - Padova
35031
Italy
Sponsor information
Organisation
Fidia Advanced Biopolymers Srl (Italy)
Sponsor details
Via Ponte della Fabbrica 3/B
Abano Terme
35031
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fidia Advanced Biopolymers Srl (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list