DIABETIC FOOT ULCERS AND POLYDEOXYRIBONUCLEOTIDE (PLACENTEX® INTEGRO MASTELLI) AS A TREATMENT FOR WOUND HEALINGMULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, PARALLEL GROUP, CLINICAL TRIA

MASTELLI SR0 个研究点目标入组 250 人开始时间: 2009年3月3日最近更新: 2022年8月8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

•?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