DIABETIC FOOT ULCERS AND POLYDEOXYRIBONUCLEOTIDE (PLACENTEX INTEGRO MASTELLI) AS A TREATMENT FOR WOUND HEALING - ND

Conditions: Diabetic foot ulcer
MedDRA version: 9.1Level: LLTClassification code 10056340Term: Diabetic ulcer

Registration Number: EUCTR2007-006754-26-IT

Lead Sponsor: MASTELLI SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Male and female patients must be aged between 45 and 80 years.
Minimum schooling 5 years.
Patient with type I or II diabetes since at least 5 years, with a stable metabolic picture
Patient?s foot ulcer been present for a minimum of 2 weeks under the current investigator?s care
Patient?s foot ulcer size: 1.0 cm2 and < 16.0 cm 2 at day 0
Patient?s ulcer grade 1 or 2 of Wagner scale
Patient?s wound free of necrotic debris and appears to be made up of healthy vascularized tissue
Patient with adequate circulation to the foot as evidenced by: transcutaneous oxygen tension (TcPO2) measured at the dorsum of the foot exhibiting the ulcer and or >29 mmHg and/or ankle/brachial blood-pressure index >0,9
If female, she will not be pregnant nor lactating. In case of sexual acts, she agrees to use appropriate contraceptive measures during the whole study period.
All patients must give their written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of one or more of the following criteria will exclude the patient from the trial:
Non-consenting patient who have not given their written consent to participation in the trial.
History of alcohol or drug abuse.
Pregnancy and lactation.
Gangrene on any part of the affected foot
Ongoing infection without treatment
Patient?s ulcer over a Charcot deformity
Ulcer total surface area: >16 cm2
Patient with a non-study ulcer on the study foot that is located within 7.0 cm of the study ulcer at day 0
Patient who at present or during the last month took part in another clinical study.
Patient taking at present or in the last 10 days systemic cicatrizant drugs
Patient suffering of severe malnutrition
Patients receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
Signs and symptoms of neurological and/or psychiatric pathologies requiring treatment.
Severe liver or kidney insufficiency.
Other severe, ongoing pathologies of an internal or surgical nature.
Proven hypersensitivity to polydeoxyribonucleotide or related drugs.
Patient whom the Investigator deems to be unhelpful or unreliable for the purposes of the study.