se of Nexodyn in the local standard therapy of chronic infected ulcers

Not Applicable

Completed

• Conditions: Chronic wounds; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN75035690
• Lead Sponsor: APR Applied Pharma Research SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Study Completion: 2017-01-31
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Patients legally able to give their written informed consent to the trial
2. Male and female patients aged =18 years with no limitation of race
3. Presence of a chronic wound (onset at least 4 weeks before enrolment) presenting the following characteristics:
3.1. Presence of infection (contamination, colonization and critical colonization) diagnosed according to clinical signs
3.2. Total ulcer size =5 cm2 involving the derma, without visible exposure of tendon or bone.
3.3. WBP score equal to B2, B3, C1, C2 or C3
4. Ankle Brachial Pressure Index (ABPI) =0.60 in the affected limb, for venous ulcers
5. Patients with clinical signs and laboratory results of atypical ulcer etiology
6. Patients who have access, for the duration of the study, to reliable outpatient care (self, family member, nursing staff, regular visits at hospital, etc.)
7. Patients who will be available for the entire study period, and will be able and willing to adhere to protocol requirements

Participants may have multiple ulcers but only ONE will be considered the target ulcer that must be identified prior the inclusion in the study

Exclusion Criteria

1. Patients with wounds characterized by the presence of necrotic dry eschar
2. Pregnant or lactating women, and women of childbearing potential not following an adequate contraceptive method
3. Diagnosis or suspect of septicemia, immunodeficiency and, in patients with venous ulcers, diagnosis or suspect of autoimmune diseases
4. Severe chronic diseases or conditions (class IV cardiac failure, uncontrolled arterial hypertension, hepatic failure, renal failure, malignancy in advanced phase, any myelopathy, anemia, chemotherapy).
5. Patients on ongoing therapy with immunosuppressive drugs or who used immunosuppressive drugs in the 4 weeks previous to study entry, except the subjects with atypical ulcer etiology under immunosuppressive maintenance therapy.
6. Patients on ongoing therapy with systemic antibiotics or who used systemic antibiotics in the 4 weeks previous to study entry.
7. Patients on ongoing therapy with drugs or medical devices active on the ulcer evolution, such as, but not limited to, collagens, hydrogels, hydrocolloids, etc.
8. Any condition that, in the opinion of the investigator, would preclude adherence or compliance to the study (e.g. chronic alcoholism, illicit drug abuse/dependence, personality disorder, relevant cognitive impairment).
9. Known allergy or intolerance to ingredients or excipients of the formulation of Nexodyn.
10. Participation, within the past 3 months prior to the start of the study, in any clinical trial, including individuals previously enrolled in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified