Negative Pressure Vs. Compression in Venous Ulcers (NCT03688841) | Clinical Trial Compass
CompletedNot Applicable
Negative Pressure Vs. Compression in Venous Ulcers
Ireland50 participantsStarted 2016-01-19
Plain-language summary
This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or more
* Provide written informed consent
* Venous ulcer present, greater than 10cm2 in surface area
* A C6 grading in the CEAP classification
Exclusion Criteria:
Pregnant (confirmed by β-HCG analysis). Female patients of childbearing potential are advised to adhere to an appropriate form of contraception, and those unwilling to follow contraceptive advice are excluded from the study
* Involvement in another clinical trial in the previous six months
* Legal incapacity
* Patient is bed-ridden or immobile
* Ulcer smaller than 10cm2 in surface area
* Ischaemic ulcer/s present
* Diabetic ulcer/s present
* Malignant ulceration/s present
* Ulcer exposing bone or tendon
* Osteomyelitis
* Pseudomonas infection
* Presence of gangrene
* Deep venous thrombosis (DVT) present
* Connective tissue disease present
* Presence of any illness that could limit long-term compliance (e.g. epilepsy)