DEep VEin Lesion OPtimisation (DEVELOP) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2024-09-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Group

Endovenous ablation + iliac US +/- iliac stenting

Group Type EXPERIMENTAL

Endovenous ablation + iliac US +/- iliac stenting

Intervention Type DEVICE

Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required

Control Group

Endovenous ablation of Great Saphenous Vein

Group Type ACTIVE_COMPARATOR

Endovenous ablation of Great Saphenous Vein

Intervention Type DEVICE

Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Interventions

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Endovenous ablation + iliac US +/- iliac stenting

Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required

Intervention Type DEVICE

Endovenous ablation of Great Saphenous Vein

Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Intervention Type DEVICE

Other Intervention Names

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Graduated Compression Stockings Iliac vein intravascular ultrasound Iliac vein stenting Graduated Compression Stockings

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes