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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT05456568
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of lymphoedema (either primary or secondary) affecting lower or upper limbs
* Known to local lymphoedema services and receiving ongoing treatment for their lymphoedema
* Age 18 and over
* Able to given informed written consent
* Able to safely use the Pump, following written and / or verbal instruction in English or Welsh
Exclusion Criteria:
* Cognitive impairment / unable to safely use the Pump at home
* Truncal / root of extremity oedema
* Known or suspected deep vein thrombosis
* Known or suspected pulmonary embolism
* Thrombophlebitis
* Active or suspected cellulitis
* Severe peripheral neuropathy
* Uncontrolled or severe congestive heart failure
* Pulmonary oedema
* Ischaemic vascular disease
* Active cancer / metastases affecting the area of lymphoedema / undergoing cancer treatment
* Untreated ulcer / wounds
* Urinary of faecal incontinence (for patients with lower limb lymphoedema only)
* History of clostridium difficile
* Unable to communicate in English or Welsh
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05456568
Study Brief:
Protocol Section:
NCT05456568