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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03186560
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to enter the study patients must meet the following criteria:
* Age ≥ 18 years
* Intact healthy skin at the site of device application
* Able to understand the Patient Information Sheet
* Willing and able to give informed consent
* Willing and able to follow the requirements of the protocol
* Specific inclusion criteria for the subgroups:
Group A: Arterial Leg Ulcer
* Defined as healing/non-healing Group B: Mixed Leg Ulcer (only to be done once Arterial leg ulcers show change in flux)
* ABPI of \<0.8-0.6 Group C: Diabetic Foot Ulcer - neuropathic
* On clinical inspection present as neuropathic Group D: Diabetic Foot Ulcer - neuroischemic
* On clinical inspection present as neuroischemic
Exclusion Criteria:
Patients will not be admitted to the study if they meet any of the following exclusion criteria:
* Significant (not colonialization) Wound infection either acute or chronic??
* History of significant haematological disorders or DVT with the preceding six months
* Pregnant
* Pacemakers or implantable defibrillators
* Use of any other neuro-modulation device
* Current use of TENS in pelvic region, back or legs
* Use of investigational drug or device within the past 4 weeks that may interfere with this study
* Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
* Recent trauma to the lower limbs that will prevent stimulation of the leg with geko (non-responders)
* Size of leg incompatible with the geko™ device., i.e prevents device from stimulating the common peroneal nerve
* obesity (BMI \> 35)
* Any medication deemed to be significant by the Investigator
* Specific exclusion criteria for different subgroups:
Group A: Arterial Leg Ulcer - Mixed leg ulcer, diabetic foot ulcer or diabetic foot ulcer with neuroischaemic element.
Group B: Mixed Leg Ulcer
\- Arterial leg ulcer, diabetic foot ulcer or diabetic foot ulcer with neuroischaemic element.
Group C: Diabetic Foot Ulcer - Mixed leg ulcer, Arterial leg ulcer, or diabetic foot ulcer with neuroischaemic element.
Group D: Diabetic Foot Ulcer - neuroischemic
\- Mixed leg ulcer, Arterial leg ulcer or diabetic foot ulcer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03186560
Study Brief:
Protocol Section:
NCT03186560