Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
NCT Number: NCT02838251
About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD) associated. The compression band is still a controversial issue in this context. It allows the reduction of venous hypertension and edema, but it could potentially degrade the arterial infusion of high levels of compression. The French High Authority for Health (HAS) defines mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with moderate involvement for IPS values between 0.7 and 0.9.
Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg. In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter compression, bit by elastic bands (exercising low power compression at rest) under medical supervision, informing the patient to remove the bandage if pain or aggravation. It is therefore necessary to adapt the compression therapy in case of venous ulcers associated with arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6 against indicates compression.
A recent study showed that compression bit elastic bands could not only improve venous return, but it would also increase the distal arterial flow in a patient population with mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients below the threshold of 0.6 indicates that against a compression according to HAS. To our knowledge this is the only study that has examined the effect of compression on blood perfusion.
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Notify Me18 year and older
All sexes
Observational
Paris, Île-de-France Region, 75014, France
Objectives:
Methodology :
o Evaluation of tolerance:
o distal arterial pressures of the compression carrier leg:
In case of bad tolerance of compression at any time after installation, the compression will be removed and the study stopped for the patient in question. Poor tolerance is defined by an increase in pain than or equal to 2 points on the digital scale.
expected benefits for patients:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The mixed origin of the ulcer is defined by a venous disease (reflux in the superficial veins and / or deep) and a moderate arterial disease, defined by:
Inclusion criteria
Exclusion criteria
Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Measuring pressure exerted by low elastic bandages by Kikuhime® system.
Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Fondation Hôpital Saint-Joseph
Other
Acronym: ULCEREMIXTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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