Venous Leg UlcerDevelopNCT03640689
DEep VEin Lesion OPtimisation (DEVELOP) Trial
A study testing Endovenous ablation + iliac US +/- iliac stenting and Endovenous ablation of Great Saphenous Vein in people with Venous Leg Ulcer, run by National University of Ireland, Galway, Ireland at 2 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Endovenous ablation + iliac US +/- iliac stenting and Endovenous ablation of Great Saphenous Vein
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIreland
- Study dates
- 15 Jul 2019to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting patients
- aged 18 and over
- ultrasound detected Great Saphenous Venous incompetence
- an associated primary or recurrent lower limb venous ulcer(s)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites, 2 recruiting
- Recruiting
Soalta Hospital Group
Galway, 0000
Thomas m Aherne, MBBCHBAO, 091542000, thomasaherne@rcsi.com
Stewart R Walsh, MBBCHBAO
- Recruiting
Univsersity Hospital Galway
Galway, 0000
Thomas M Aherne, MBBChBAO, MCh, 091542000, tommyaherne@hotmail.com
About this study
Official title: DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers
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.
Read the 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
- 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
- Venous Leg Ulcer
- Being tested
- Endovenous ablation + iliac US +/- iliac stenting, Endovenous ablation of Great Saphenous Vein
- Keywords
- Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous ablation + iliac US +/- iliac stentingDevice
Also called Graduated Compression Stockings, Iliac vein intravascular ultrasound, Iliac vein stenting
Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required
Endovenous ablation of Great Saphenous VeinDevice
Also called Graduated Compression Stockings
Ablation of the Great Saphenous Vein and subsequent Graduated Compression
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Endovenous ablation + iliac US +/- iliac stenting Receives: Device: Endovenous ablation + iliac US +/- iliac stenting |
| Control Group | Active comparator | Endovenous ablation of Great Saphenous Vein Receives: Device: Endovenous ablation of Great Saphenous Vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Healing - Proportion of ulcers healed
Proportion of ulcers healed
Measured: 3-months
Iliac Vein Patency on duplex ultrasound
Patency of the iliac vein on duplex
Measured: 6-months
Reintervention
Freedom from re-intervention
Measured: 12-months
Secondary outcomes (3)
Ulcer healing - Time to ulcer healing
Time to ulcer healing
Measured: In days
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.
Measured: 12-months
Recurrence - Ulcer recurrence
Ulcer recurrence
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Jul 2019
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Aherne, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640689
- Sponsor's protocol ID
- NUIreland1
- Acronym
- Develop
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 33541436
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03640689
- Acronym / sponsor ID
- Develop / NUIreland1
- Conditions
- Venous Leg Ulcer
- Keywords
- Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Endovenous ablation + iliac US +/- iliac stentingEndovenous ablation + iliac US +/- iliac stenting |
| Control Group | Active comparator | Device: Endovenous ablation of Great Saphenous VeinEndovenous ablation of Great Saphenous Vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting patients
- aged 18 and over
- ultrasound detected Great Saphenous Venous incompetence
- an associated primary or recurrent lower limb venous ulcer(s)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous ablation + iliac US +/- iliac stentingAlso: Graduated Compression Stockings, Iliac vein intravascular ultrasound, Iliac vein stentingConcomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required | Device | Intervention Group |
| Endovenous ablation of Great Saphenous VeinAlso: Graduated Compression StockingsAblation of the Great Saphenous Vein and subsequent Graduated Compression | Device | Control Group |
Primary outcome
Ulcer Healing - Proportion of ulcers healed
Time frame: 3-months
Proportion of ulcers healed
Iliac Vein Patency on duplex ultrasound
Time frame: 6-months
Patency of the iliac vein on duplex
Reintervention
Time frame: 12-months
Freedom from re-intervention
3 secondary outcomes
Ulcer healing - Time to ulcer healing
Time frame: In days
Patient Quality of life using the Aberdeen Varicose Vein Questionnaire
Time frame: 12-months
Recurrence - Ulcer recurrence
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 33541436Aherne 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovenous ablation + iliac US +/- iliac stenting and Endovenous ablation of Great Saphenous Vein in people with Venous Leg Ulcer, run by National University of Ireland, Galway, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Healing - Proportion of ulcers healed (time frame: 3-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.