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DEep VEin Lesion OPtimisation (DEVELOP) Trial (Develop)

Primary Purpose

Venous Leg Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Endovenous ablation + iliac US +/- iliac stenting

Endovenous ablation of Great Saphenous Vein

About this trial

This is an interventional diagnostic trial for Venous Leg Ulcer focused on measuring Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Soalta Hospital GroupRecruiting
Univsersity Hospital GalwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Endovenous ablation + iliac US +/- iliac stenting

Endovenous ablation of Great Saphenous Vein

Outcomes

Primary Outcome Measures

Ulcer Healing - Proportion of ulcers healed

Proportion of ulcers healed

Iliac Vein Patency on duplex ultrasound

Patency of the iliac vein on duplex

Reintervention

Freedom from re-intervention

Secondary Outcome Measures

Ulcer healing - Time to ulcer healing

Time to ulcer healing

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.

Recurrence - Ulcer recurrence

Ulcer recurrence

Full Information

NCT ID

NCT03640689

First Posted

August 14, 2018

Last Updated

March 2, 2021

Sponsor

National University of Ireland, Galway, Ireland

1. Study Identification

Unique Protocol Identification Number

NCT03640689

Brief Title

DEep VEin Lesion OPtimisation (DEVELOP) Trial

Acronym

Develop

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Ireland, Galway, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

Keywords

Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Endovenous ablation + iliac US +/- iliac stenting

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Endovenous ablation of Great Saphenous Vein

Intervention Type

Device

Intervention Name(s)

Endovenous ablation + iliac US +/- iliac stenting

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Endovenous ablation of Great Saphenous Vein

Other Intervention Name(s)

Graduated Compression Stockings

Intervention Description

Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Primary Outcome Measure Information:

Title

Ulcer Healing - Proportion of ulcers healed

Description

Proportion of ulcers healed

Time Frame

3-months

Title

Iliac Vein Patency on duplex ultrasound

Description

Patency of the iliac vein on duplex

Time Frame

6-months

Title

Reintervention

Description

Freedom from re-intervention

Time Frame

12-months

Secondary Outcome Measure Information:

Title

Ulcer healing - Time to ulcer healing

Description

Time to ulcer healing

Time Frame

In days

Title

Patient Quality of life using the Aberdeen Varicose Vein Questionnaire

Description

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.

Time Frame

12-months

Title

Recurrence - Ulcer recurrence

Description

Ulcer recurrence

Time Frame

12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Soalta Hospital Group

City

Galway

ZIP/Postal Code

0000

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas m Aherne, MBBCHBAO

Phone

091542000

thomasaherne@rcsi.com

First Name & Middle Initial & Last Name & Degree

Stewart R Walsh, MBBCHBAO

Facility Name

Univsersity Hospital Galway

City

Galway

ZIP/Postal Code

0000

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas M Aherne, MBBChBAO, MCh

Phone

091542000

tommyaherne@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

1 year for 5 years

Citations:

PubMed Identifier

33541436

Citation

Aherne TM, Keohane C, Mullins M, Zafar AS, Black SA, Tang TY, O'Sullivan GJ, Walsh SR. DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers. Pilot Feasibility Stud. 2021 Feb 4;7(1):42. doi: 10.1186/s40814-021-00779-2.

Results Reference

derived

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DEep VEin Lesion OPtimisation (DEVELOP) Trial

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