A Phase 4 interventional study of polidocanol and infra-red coagulation in Ganglion Cysts, sponsored by University of Edinburgh. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by University of Edinburgh · Phase 4, Interventional, and Treatment
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Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.
42 studies on the registry are indexed under Ganglion Cysts; 7 are open to participants now.
This study's enrollment of 10 is below the median of 62 across 31 interventional studies indexed under Ganglion Cysts.
Browse Ganglion Cysts studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: polidocanol
Procedure: cryotherapy
Procedure: infra-red coagulation
cyst resolution at 6 weeks
Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?
Time frame: 6 weeks
cyst resolution at 12 and 52 weeks
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in the percentage of participants with cyst resolution at 12 and 52 weeks post initial treatment
Time frame: 1 year
difference in scarring
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring
Time frame: 1 year
pain scores on a visual analogue scale
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure pain/discomfort
Time frame: 1 year
procedure satisfaction on a visual analogue scale
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction
Time frame: 1 year
Ran from Jul 2015 to primary completion in Oct 2015, 2 months.
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Polidocanol