Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • treatment: puncture of coagulation

    Procedure/Surgery

    ultrasound-guided puncture of coagulation

  • treatment: sclerosing agent injected

    Procedure/Surgery

    ultrasound-guided sclerosing agent injected

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: experimental group (electrocoagulation)Experimental treatment 1 intervention
Group B: control group (sclerotherapy)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

IPVs occlusion rate in the 12th month.

IPVs occlusion rate is defined as DS \> 50% for each modality with no procedure no procedure performed on the treated segment

Time frame
12 months after operation

Secondary outcomes

1

Quality of life scale survey results

quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score).Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).

Time frame
1-month,6-month,12-month
2

Skin ulcer recurrence rate

Skin ulcer recurrence

Time frame
1-month,6-month,12-month
3

Proportion of participants with deep venous Thrombosis

deep venous Thrombosis

Time frame
1-month,6-month,12-month
4

Proportion of participants with hemorrhage

Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding

Time frame
1-month,6-month,12-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Sir Run Run Shaw Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Yantai Yuhuangding Hospital

Collaborator

Anhui Provincial Hospital

Collaborator