Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/06/2009
Date assigned
11/08/2009
Last edited
11/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Doriana Senigaglia

ORCID ID

Contact details

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

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 measures

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

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

http://www.fidiapharma.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes