non-healing skin wounds
Conditions
Interventions
Trade Name: Evicel
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: fibrinogen
Other descriptive name: HUMAN CLOTTABLE PROTEIN CONTAINING MAINLY FIBRINOGEN AND FIBRONECTIN
Concentration un
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic, non-infected wound on either the foot or leg (Texas classification grade 1 or 2, stage A or C) that is non-respondent to treatment for at least 6 weeks. - The size of the wounds must be between 1-20 cm2. - Older than 18 years. - BMI =65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - Patient suffers from osteomyelitis, cellulitis, gangrene or any other type of infection on the investigated leg. - Patient is known with an anaphylactic / severe systemic reaction towards human blood products. - Patient is known with alcohol or drug abuse. - It is impossible to correctly inform the patient (language barrier, mental problems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): healed wound or the decrease in wound area after 12 weeks of treatment, the endpoint of the trial;Timepoint(s) of evaluation of this end point: week 0, 2, 4, 6, 8, 10, 12;Main Objective: Primary Objective: increase in number of healed wounds during trial;Secondary Objective: decrease in wound volume at week 12, wound tissue perfusion; quality of life scoring; VAS pain scoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Netherlands
Outcome results
None listed