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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05659394
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Presence of at least one hard to heal\*, venous or mixed (of both venous and arterial origin) aetiology lower limb wound
* ABPI ≥ 0.6, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out significant peripheral arterial disease i.e. doppler auscultation, toe pressure assessment (Absolute Toe Pressure ≥40mmHg ) or arterial imaging
* Has received high static compression therapy (in the form of bandages, wraps or hosiery) during the preceding 4 weeks and is willing to continue receiving appropriate static compression therapy for their ulcer aetiology for the duration of the study
* Receiving standard wound care as per investigator discretion which will continue regardless of study participation
* Able and willing to give informed consent for participation in study
* Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16 week period
* Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo a pregnancy test at screening
* Failure of wound to progress towards healing (as indicated by decrease in surface area by ≥ 25%) in preceding month, despite appropriate and adequate compression therapy.
Exclusion Criteria:
* Wound surface area ≥ 100cm2
* Wound duration ≤ 2 months or ≥ 5 years
* Diabetic patients with recent HbA1c \>8.5
* Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis and acute infections of the skin, such as cellulitis
* Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimental
* Severe arteriosclerosis or other ischemic vascular disease
* Leg ulcers without a venous component to their aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates compression (ABI \< 0.6 or Absolute Toe Pressure \<40mmHg)
* Known malignancy
* Patient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
* Current participation in any other clinical trial
* Patient likely to miss more than five days of therapy (e.g. for planned holiday)
* Thigh circumference \>90cm (maximum garment size)
* Any wounds, infection or dermatological conditions that would be adversely affected by placement of the thigh garment
* Subject is pregnant or breast-feeding
Ɨ within preceding 3 months
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05659394
Study Brief:
Protocol Section:
NCT05659394