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Immediate Versus Early Endovenous Ablation In Venous Ulcer

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ClinicalTrials.gov Identifier: NCT03795064
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Toni Pihlaja, Oulu University Hospital

Brief Summary:
The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

Condition or disease Intervention/treatment Phase
Venous Ulcer Drug: Sodium Tetradecyl Sulfate Not Applicable

Detailed Description:
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic. Patients in control group will be treated in early setting. Endothermal ablation is performed to both groups when possible in early setting.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Versus Early Endovenous Ablation In Venous Ulcer
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Immediate Intervention
Patients in this group will be treated with foam sclerotherapy immediately at first visit to outpatient clinic.
Drug: Sodium Tetradecyl Sulfate
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins related to active venous ulcer.

Active Comparator: Early Intervention
Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic
Drug: Sodium Tetradecyl Sulfate
Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins related to active venous ulcer.




Primary Outcome Measures :
  1. Venous ulcer area [ Time Frame: 0 to 180 days ]
    Venous ulcer area measured from calibrated digital photograph.


Secondary Outcome Measures :
  1. Time to ulcer healing [ Time Frame: 0 to 360 days ]
    Complete re-epithelialisation of ulcer area.

  2. Total time of active venous ulcer [ Time Frame: 0 to 360 days ]
    Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Venous ulcer > 1 month
  • Palpable distal pulses / Ankle-brachial index > 0,8 / Toe-brachial index > 70mmhg (at least one criteria must be met)

Exclusion Criteria:

  • Leg ulcers other than venous etiology
  • Pregnancy
  • General contraindications for foam sclerotherapy
  • Ulcers requiring surgical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795064


Contacts
Contact: Matti Pokela, Docent 0883152011 ext 358 matti.pokela@ppshp.fi

Locations
Finland
Oulu University Hospital, Vascular Department Recruiting
Oulu, Finland, 90220
Contact: Matti Pokela, Docent    +35883152011    matti.pokela@ppshp.fi   
Principal Investigator: Toni Pihlaja, M.D.         
Sponsors and Collaborators
Oulu University Hospital

Responsible Party: Toni Pihlaja, Vascular Specialist, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT03795064     History of Changes
Other Study ID Numbers: 268/2018
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Toni Pihlaja, Oulu University Hospital:
Venous Ulcer
Venous Insufficiency of Leg
Varicose Veins

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Sodium Tetradecyl Sulfate
Sclerosing Solutions
Pharmaceutical Solutions