Finnish Venous Ulcer Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oulu University Hospital
- Enrollment
- 248
- Locations
- 5
- Primary Endpoint
- Time to ulcer Healing
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.
Detailed Description
To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing. In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s). Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year. For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group. Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).
Investigators
Toni Pihlaja
Principal Investigator
Oulu University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patient informed consent
- •Venous ulcer, aged from one month to one year
- •Duplex ultrasonography verified (vein reflux greater than \>0.5 second) superficial venous insufficiency
- •Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index \> 0,8 / Toe pressure \>60mmhg)
Exclusion Criteria
- •Leg ulcers other than venous etiology
- •Ulcers requiring operation theater revision
- •Patent foramen ovale
- •Several times recurrent (over 3 recurrences) venous ulcer
- •Body Mass Index over 40
- •Pregnancy
Outcomes
Primary Outcomes
Time to ulcer Healing
Time Frame: 0-365 days
Complete re-epithelialisation of ulcer area
Secondary Outcomes
- EQ-5D Questionnaire(0-365 days)
- Venous ulcer area(0-365 days)
- Wound-QOL Questionnaire(0-365 days)