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

MASTELLI SR0 个研究点开始时间: 2008年2月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

MASTELLI SR