Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00627094
Eligibility Criteria:
Inclusion Criteria:
* \>= 18 years of age
* Chronic venous leg ulcer on the lower leg
* Ulcer duration \>= 8 weeks
* Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
* Exudate level moderate to high
* Ulcer size min 1.6 cm and max 11 cm in any direction
* Ankle/brachial index \>= 0.8
* Treated with moist wound healing during the past 2 weeks prior to inclusion
* Adequate compression therapy during the past 2 weeks prior to inclusion
* The patient is cognitive capable of evaluating his/her pain relief and pain intensity
* The patient is able to understand the treatment and is willing to comply with the treatment regimen.
* The patient is able to complete the patient diary
* The patient is willing and able to give written informed consent
Exclusion Criteria:
* Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
* Pregnant or lactating women
* Known and verified hypersensitivity to any content of the products used in this investigation
* Local infection (bacterial imbalanced wound) in the study ulcer
* Clinical infection in the study ulcer
* Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
* The investigator considers the patient not eligible
* Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
* Diabetes
* Use of per need medication for the past 3 days
* Concomitant treatment with systemic antibiotics other than nitrofurantoin
* Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
* Concomitant treatment with cancer chemotherapeutics
* Concomitant participation in other studies
* Previous participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00627094
Study Brief:
Protocol Section:
NCT00627094