Chronic stasis ulcer MedDRA version: 13.1 Level: LLT Classification code 10047246 Term: Venous stasis ulcer System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - at least one chronic wound without signs of infection - age >=50 years - at least 6 months peristence without significant recovery despite optimal wound care, the wound must measure between 2.24cm2 and 64cm2 - 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - pregnant and nursing women, - pre-existing severe hepatic or renal insufficiency - pre-existing of hepatitis - chronic severe focus of infection - severe wound infection - known hypersensitivity to Adalimumab or other components of the IMP - signs of latent or active tuberculosis - decompensated cardiac insufficiency (NYHA III/IV) - lack of treatment compliance - active demyelinating or other neurological disorder - malignant or lymphoproliferative disorder - known autoimmune disorder - consumption of other immunosuppresive drugs - women of child bearing potential (< 2 years after last menstruation) - concurrent participation in other studys - individuals dependent on investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there a significant influence on wound healing in chronic wounds after regular treatment did not improve wound healing any further?;Secondary Objective: Secondary questions of the study concern: - occurrence of new or aggravation of an existent infection. - pain associated with chronic wound - occurrence of potential contraindications ;Primary end point(s): Reduction of wound area under serial treatment with Adalimumab;Timepoint(s) of evaluation of this end point: End of application series, i.e. day 8 (+/-2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - course of wound area during treatment - wound pain (visual analogue scale) - occurence or incidence of infections - results of mikrobiologic swab, in case of clinical suspicion of infection - development of possible contraindications (each visit; following the SmPC) - development of TNF-alpha-antibodies - other (S)AE;Timepoint(s) of evaluation of this end point: every visit, i.e. days 1-8 and Follow-up: 4 and 12 weeks after last application of IMP | — |
Countries
Germany
Contacts
Public ContactCoordination Centre for Clinical Tr
Clinical Trial Centre Leipzig - KKS
Outcome results
None listed