Venous disease/leg ulcers Circulatory System Ulcer of lower limb, not elsewhere classified
Conditions
Interventions
Standard therapy consisting of multilayer elastic compression bandaging with deferred treatment of superficial reflux (usually once the ulcer has healed) vs early endovenous treatment of superficial v
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Current leg ulceration of greater than 6 weeks, but less than 6 months duration 2. Able to give informed consent to participate in the study after reading the patient information documentation 3. Patient age > 18 years 4. Ankle Brachial Pressure Index (ABPI) greater than or equal to 0.8 5. Superficial venous disease on colour duplex assessment deemed to be significant enough to warrant ablation by the treating clinician (either primary or recurrent venous reflux) Patients who cannot speak/understand English will be eligible for inclusion and informed consent will be obtained with assistance from translation services as per standard clinical practice. In view of the lack of cross cultural validation for quality of life tools, only healing outcome data will be collected.
Exclusion criteria
Exclusion criteria: 1. Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention 2. Patients who are unable to tolerate any multilayer compression bandaging will be excluded. However, concordance with compression therapy can be variable for patients at different times. Patients who are generally compliant with compression but unable to tolerate the bandages for short periods will still be eligible for inclusion. A period of noncompliance with compression bandages will not be considered a protocol violation, but a normal variation within the spectrum of standard therapy. 3. Inability of the patient to receive prompt endovenous intervention by the recruiting centre 4. Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation) 5. Leg ulcer of nonvenous aetiology (as assessed by the responsible clinician) 6. If patient is deemed to require skin grafting they cannot be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to ulcer healing (from date of randomization to date of healing) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/10/2018: 1. Ulcer Healing Rate: Healing rate will be evaluated in addition to time to ulcer healing to allow comparison with other published studies. 2. Ulcer recurrence/Ulcer Free Time: Will be calculated up to 1 year for each study arm and with the extension, up to 5 years (median approximately 3.7 years). This will allow a very practical and easily understood assessment of the clinical difference between the 2 arms of the study. This will also allow comparison with other studies that have reported this outcome. In order to facilitate accurate calculation of reoccurrence/ulcer free time, clinical follow up will be continued after ulcer healing up to 1 year after randomisation. 3. Quality Of Life (QoL): Disease specific (AVVQ) and generic (EQ5D & SF36) quality of life assessments will be compared at 6 weeks post randomisation, 6 months, 12 months and at one time point between October 2018 and March 2019. The 6-week questionnaire will be given to the patient at the follow-up appointment, whereas other QoL questionnaires will be sent to the patient or completed by the patient via telephone. AVVQ is the most widely utilised disease specific QoL tool in venous disease and has been extensively validated. A score out of 100 points is calculated, with a higher score indicating more severe QoL impairment. Changes in QoL scores will offer a comparison with other studies and, in the standard treatment arm, will allow an assessment of the natural history of venous ulceration treated with compression. 4. Health Economic Assessment: Cost items in hospital and community care will be recorded for each patient. Standard HRG published tariffs will be used to calculate overall costs. A standard tariff will be applied for each bandage change, although additional treatments administered for the treatment of symptoms or complications directly related to venous ulceration will be | — |
Countries
United Kingdom
Contacts
Public ContactFrancine Heatley
Outcome results
None listed