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:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT02845466
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥18 years
* Ulcer size 1-64 cm²
* Ulcer extends through both the epidermis and dermis, with no exposed tendon or bone
* Ulcer duration \>3 months
* Ulcer located between and including the knee and ankle
* For venous leg ulcers - Venous refilling time \<25s on photoplethysmography or abnormal venous insufficiency Duplex scan
* For diabetic foot ulcers - confirmed type 1 or type 2 diabetes mellitus with a haemoglobin A1C \< 12%
* Wounds have not been treated with Promogran in the previous 4 weeks
* Patients able to give informed consent
Exclusion Criteria:
* Ankle-brachial index \<0.8
* Ulcer with local or systemic signs of infection
* Patients who have been previously treated with Becaplermin gel
* Receiving corticosteroids or immune suppressants
* History of autoimmune disease
* Uncontrolled diabetes (baseline haemoglobin A1C \> 12%)
* Severe rheumatoid arthritis
* Uncontrolled congestive heart failure
* Malnutrition (albumin \<2.5g/dL)
* Unable to adhere to the protocol
* Known sensitivities to the wound dressings used in the trial
* A history of any previous malignancy
* pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02845466
Study Brief:
Protocol Section:
NCT02845466