Diabetic foot ulcer MedDRA version: 9.1 Level: LLT Classification code 10056340 Term: Diabetic ulcer
Conditions
Interventions
Trade Name: PLACENTEX INTEGRO*IM SC 5F 3ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: POLIDERIBOTIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
MASTELLI SRL
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this clinical trial is to evaluate the efficacy of the polydeoxyribonucleotide (active drug) in improving the healing of diabetic foot ulcers.;Secondary Objective: The second end point is to confirm the safety and the tolerability of the active compound.;Primary end point(s): 1. Complete wound closure (100%) | — |
Countries
Italy, Slovenia
Outcome results
None listed