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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05057793
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥ 18 years, able to provide written informed consent and comply with all study procedures and visit schedule
2. Intact healthy skin at the site of geko™ device application.
3. Have a (chronic) venous leg ulcer determined to be due to underlying venous disease following evaluation in a multi-professional setting or by a vascular surgeon, specialist physician or nurse wound specialist in accordance with Wounds Canada (2018), Health Quality Ontario Standards
4. A VLU of approximately ≥ 5cm2 and ≤ 40cm2 at study enrolment i.e. Run in Phase Visit 1. If more than one ulcer is present, the largest ulcer within the given size range will be designated the study ulcer and the only one included in the study. If other ulcerations are present on the same leg, they must be more than 2 cm apart if they are two separate wounds.
5. Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry.
6. Ankle-Brachial Pressure Index (ABPI) of 0.8 -1.2 ± 0.05 inclusive (or equivalent measure) measured at study entry or within 12 weeks of study entry.
7. No active local index wound infection for a minimum of 48 hours prior to study entry (RV1)
8. No systemic antimicrobial treatment for a minimum of seven days prior to study entry (RV1) prescribed for index wound infection
9. Must understand and is willing and able to participate in the study and to comply with all study procedures and study visit schedule
Exclusion Criteria:
1. Known allergy or intolerance to any of the protocol-stipulated treatments
2. History of significant haematological disorders (e.g. Sickle Cell disease)
3. History of Deep Vein Thrombosis (DVT) within six months preceding study entry
4. History of Pyoderma Gangrenosum or other inflammatory ulceration
5. BMI ≥ 40
6. Pregnancy or risk of pregnancy
7. Use of investigational drug or device within four weeks prior to study entry that may interfere with the study
8. Use of any neuro-modulation device
9. Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement)
10. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
11. Implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
12. Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. higher dose systemic steroids).
13. Participation in any other clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05057793
Study Brief:
Protocol Section:
NCT05057793