Abstract
BackgroundVenous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration.An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy.MethodsThis is a prospective, multi-centre, randomised controlled, feasibility trial recruiting patients with lower limb venous ulceration and saphenous venous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (> 50%) iliac vein lesions plus compression therapy. The primary feasibility outcome will be the rate of eligible patient participation while the primary clinical outcomes will be ulcer healing and procedural safety. Secondary outcomes include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow-up will be over a 5-year period. This feasibility trial is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the trial to definitively address ulcer-healing rates.DiscussionThis trial will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to superficial truncal venous incompetence.Ethical committee referenceC.A. 2111 Galway Clinical Research Ethics CommitteeRegistrationClinical Trials.gov registration NCT03640689, Registered on 21 August 2018.
Highlights
Venous leg ulceration is a widespread, debilitating pathology with high recurrence rates
Conservative measures including regular ulcer dressing with compression bandaging are well established
This approach offers undoubted benefits improving both ulcer healing rates and reducing recurrence [5, 24] in the longer term. This approach can be slow with a median ulcer healing time of up to 99 days [5] and high rates of non-compliance [24]
Summary
Venous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Superficial venous ablation encourages ulcer healing and reduces recurrence. Many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration. An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. Leg ulcers are a widespread, debilitating problem with a prevalence in Ireland of 0.12% overall This increases to 1% among patients over 70 years of age. Recurrence is common with 12-month healing rates reported between 16 and 36% [1] The majority of these leg ulcers (81%) are venous in origin and are treated in the community by public health nurses at a significant annual cost [2]. Fibrin pericapillary cuffs and/or trapping of white cells within the interstitium typically precede tissue loss with these changes leading to skin ulceration as a result of relative local tissue hypoxia or cytokine/protease release [3, 4]
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