DEep VEin Lesion OPtimisation (DEVELOP) Trial

Venous Leg Ulcer Clinical Trial

— Develop  

Official title:

DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640689
• Other study ID #: NUIreland1
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2021
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous 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 endpoints will be ulcer healing and procedural safety. Secondary endpoints 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 five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.

Description:

The single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with IVUS and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment? Primary Objective To determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone. Secondary Objectives 1. To determine the relative performance of duplex ultrasound compared to IVUS for the prediction of NIVLs 3. To determine the rate of primary or recurrent ulceration up to five years following intervention 4. To assess patient quality of life in the short and medium term following each mode of intervention

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consenting patients
• aged 18 and over
• ultrasound detected Great Saphenous Venous incompetence
• an associated primary or recurrent lower limb venous ulcer(s)

Exclusion Criteria:

• Ankle-brachial pressure index <0.8
• Previous inability to tolerate lower limb compression bandaging
• Inability to provide informed consent
• Previous lower limb arterial revascularisation procedure
• Contrast allergy
• Previous history of pelvic malignancy or pelvic radiotherapy
• Pregnancy
• Previous iliac vein intervention
• Previous superficial vein intervention
• Infection in previous 30 days
• Estimated glomerular filtration rate (eGFR) < 60 mls/kg/min
• Isolated short saphenous or perforator vein reflux only
• Leg ulcer of non-venous aetiology (as assessed by clinician)
• Unfit for endovascular intervention based on history and examination
• Any compression therapy within six-months
• Evidence of deep venous incompetence/thrombosis

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Endovenous ablation + iliac US +/- iliac stenting
Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required
• Endovenous ablation of Great Saphenous Vein
Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Locations

Country	Name	City	State
Ireland	Soalta Hospital Group	Galway
Ireland	Univsersity Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer Healing - Proportion of ulcers healed	Proportion of ulcers healed	3-months
Primary	Iliac Vein Patency on duplex ultrasound	Patency of the iliac vein on duplex	6-months
Primary	Reintervention	Freedom from re-intervention	12-months
Secondary	Ulcer healing - Time to ulcer healing	Time to ulcer healing	In days
Secondary	Patient Quality of life using the Aberdeen Varicose Vein Questionnaire	Aberdeen Varicose Vein Questionnaire measured from 0(no effect)-100(severe effect). The higher the score the greater the negative impact on patient quality of life.	12-months
Secondary	Recurrence - Ulcer recurrence	Ulcer recurrence	12-months