Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of th… (NCT03666754) | Clinical Trial Compass
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Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer
Thailand80 participantsStarted 2018-09-26
Plain-language summary
The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Current leg ulceration of greater than 6 weeks, but less than 6 months duration
* Able to give informed consent to participate in the study after reading the patient information documentation
* Patient age \> 18 years
* Ankle Brachial Pressure Index (ABPI) ≥ 0.8
* 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)
Exclusion Criteria:
* Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
* Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
* The inability of the patient to receive the prompt endovenous intervention
* Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
What they're measuring
1
Time to ulcer healing
Timeframe: time from date of randomisation to date of healing within the 12 month study period