Chronic wounds Injury, Occupational Diseases, Poisoning
Conditions
Interventions
All patients will receive a local treatment with Nexodyn twice daily plus an inert secondary dressing only for 4 weeks. Patients with venous ulcers will be allowed to use compression stockings to help
Sponsors
APR Applied Pharma Research SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving a Wound Bed Preparation (WBP) score of A1, A2, A3 or B1, measured by visually evaluating the type of tissues and the amount of exudate in the wound, during the 4-week treatment with Nexodyn | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of the WBP score at weeks 1, 2, 3 and 4 versus baseline, measured by visually evaluating the type of tissues and the amount of exudate in the wound. 2. Change of ulcer area and depth at weeks 1, 2, 3 and 4 versus baseline, measured by means of the STAR ARANZ System (a wound imaging, 3D measurement and documentation system providing accurate wound information) 3. Change of wound bed pH at weeks 1, 2, 3 and 4 versus baseline, measured by means of a non-invasive potentiometric method (a pH meter) 4. Change in the relative presence of coloured wound areas [white/black (L*), red/green (b*) and yellow/blue (c*)] at weeks 1, 2, 3 and 4 versus baseline, measured by a colorimeter (Cielab System) performing skin colour assessment 5. Change in wound-related pain at weeks 1, 2, 3 and 4 versus baseline, measured using the visual analogue score (VAS) 6. Patient’s acceptance of Nexodyn, evaluated immediately after each application according to a 4-point scale (from 1 = Very comfortable/relief sensation to 4 = Very uncomfortable/pain sensation) 7. Change of patients’ quality of life and perception of health outcomes at week 4 versus baseline, measured with the Short Form 12 (SF-12). 8. Caregiver’s assessment of product usability, measured by a 4-point scale (from 1 = excellent overall convenience to 4 = poor overall convenience) at week 4 9. Local tolerability and safety | — |
Countries
Italy
Outcome results
None listed