DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers
Abstract Background Venous 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 reduce...
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| Format: | Article |
| Language: | English |
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BMC
2021-02-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-021-00779-2 |
| _version_ | 1819275559236009984 |
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| author | Thomas M. Aherne Colm Keohane Matthew Mullins Adeel S. Zafar Stephen A. Black Tjun Y. Tang Gerard J. O’Sullivan Stewart R. Walsh |
| author_facet | Thomas M. Aherne Colm Keohane Matthew Mullins Adeel S. Zafar Stephen A. Black Tjun Y. Tang Gerard J. O’Sullivan Stewart R. Walsh |
| author_sort | Thomas M. Aherne |
| collection | DOAJ |
| description | Abstract Background Venous 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. Methods This 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. Discussion This 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 reference C.A. 2111 Galway Clinical Research Ethics Committee Registration Clinical Trials.gov registration NCT03640689 , Registered on 21 August 2018. |
| first_indexed | 2024-12-23T23:26:15Z |
| format | Article |
| id | doaj.art-ed3d2b4905cf4a5e98d02e1fe3cc2c33 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-23T23:26:15Z |
| publishDate | 2021-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-ed3d2b4905cf4a5e98d02e1fe3cc2c332022-12-21T17:26:13ZengBMCPilot and Feasibility Studies2055-57842021-02-017111210.1186/s40814-021-00779-2DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcersThomas M. Aherne0Colm Keohane1Matthew Mullins2Adeel S. Zafar3Stephen A. Black4Tjun Y. Tang5Gerard J. O’Sullivan6Stewart R. Walsh7Lambe Institute for Translational Discipline of Surgery, National University of IrelandLambe Institute for Translational Discipline of Surgery, National University of IrelandDepartment of Interventional Radiology, University Hospital GalwayLambe Institute for Translational Discipline of Surgery, National University of IrelandGuy’s and St Thomas’ N.H.S. Foundation TrustDepartment of Vascular Surgery, Singapore General HospitalDepartment of Interventional Radiology, University Hospital GalwayLambe Institute for Translational Discipline of Surgery, National University of IrelandAbstract Background Venous 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. Methods This 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. Discussion This 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 reference C.A. 2111 Galway Clinical Research Ethics Committee Registration Clinical Trials.gov registration NCT03640689 , Registered on 21 August 2018.https://doi.org/10.1186/s40814-021-00779-2Venous ulcerEndovenousDeep venous interventionIliac veinIntra-vascular ultrasoundSaphenous incompetence |
| spellingShingle | Thomas M. Aherne Colm Keohane Matthew Mullins Adeel S. Zafar Stephen A. Black Tjun Y. Tang Gerard J. O’Sullivan Stewart R. Walsh DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers Pilot and Feasibility Studies Venous ulcer Endovenous Deep venous intervention Iliac vein Intra-vascular ultrasound Saphenous incompetence |
| title | DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| title_full | DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| title_fullStr | DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| title_full_unstemmed | DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| title_short | DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| title_sort | deep vein lesion optimisation develop trial protocol for a randomised assessor blinded feasibility trial of iliac vein intervention for venous leg ulcers |
| topic | Venous ulcer Endovenous Deep venous intervention Iliac vein Intra-vascular ultrasound Saphenous incompetence |
| url | https://doi.org/10.1186/s40814-021-00779-2 |
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