Condition category
Skin and Connective Tissue Diseases
Date applied
03/04/2020
Date assigned
20/04/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Varicose veins are swollen blood vessels that are most commonly in the lower legs and feet. They may be dark blue or purple, and are often lumpy or twisted in appearance. People can experience swollen, itchy, aching and uncomfortable legs, feet and ankles. One treatment for varicose veins is called sclerotherapy, which involves an injection into the vein which causes the blood in the vein to clot and vein to collapse and shrink. One of the side effects of this treatment is that patients can be left with discolouration of the skin which can appear darker/hyperpigmented.

This study aims to find out if adding a drug called sulodexide to the standard sclerotherapy treatment for patients with varicose veins can reduce the presence of hyperpigmentation following the procedure without affecting the intended therapy of vein elimination or increasing the risk of major bleeding

Who can participate?
Patients who are aged 18 to 65 years with telangiectatic, reticular, or varicose veins in their lower limbs who are suitable candidates for sclerotherapy

What does the study involve?
Half of the participants will receive standard sclerotherapy treatment. The other half will receive sulodexide 7 days before the scheduled sclerotherapy. All participants will be advised to wear compression stockings for 7 days afterwards. At 1 and 3 months participants will return for follow up appointments to check for the success of the sclerotherapy and for hyperpigmentation.

What are the possible benefits and risks of participating?
Possible benefits of this treatment could be improved patient satisfaction, which is very important in a procedure mostly done for cosmetics reasons. Additionally, faster improvement in the emotional wellbeing and quality of life of the patient.

With the reduction of the incidence of post-sclerotherapy hyperpigmentation, the possibility to treat larger veins with sclerotherapy can be contemplated, and possibly avoid a more expensive procedure like surgical stripping; this can be important in the socioeconomic population where sclerotherapy is the only possible treatment.

Where is the study run from?
CLINEDEM, ISSSTECALI and Hospital General Issste 5 de Diciembre (Mexico)

When is the study starting and how long is it expected to run for?
From January 2018 to September 2019

Who is funding the study?
This study is investigator-initiated and funded

Who is the main contact?
Dr Alejandro Gonzalez Ochoa
2alex8as@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alejandro Gonzalez Ochoa

ORCID ID

http://orcid.org/0000-0001-5068-623X

Contact details

Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico
+526538497372
2alex8as@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

8936-042019

Study information

Scientific title

Reducing Hyperpigmentation After Sclerotherapy (RHyAS) study: a multicenter, randomized, clinical trial.

Acronym

RHyAS study

Study hypothesis

The use of sulodexide in patients with varicose vein treated with sclerotherapy can reduce the incidence of hyperpigmentation

Ethics approval

Approved 21/11/2017, the Universidad Autónoma de Baja California (Coordination de Posgrado e Investigacion. av Alvaro Obregon y Julian Carrillo s/n Colonia Nueva cp 21100
Edificio de Rectoria, Mexicali Baja California, Mexico; +52 686 551 9497; anahernandez@uabcinvestigacion.net)

Study design

Prospective, multicentric, randomized controlled trial, using a parallel-group design

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hyperpigmentation following sclerotherapy for varicose veins

Intervention

Participants who were included with telangiectasia, reticular or varicose veins who were candidates for sclerotherapy. They received Sclerotherapy using polidocanol 1% as sclerosant agent, 10ml maximum dose per session, total of 2 sessions 6 weeks apart. 20-30mmhg compression stockings were used in both groups for 7 days.

Participants were randomly assigned, in a 1:1 ratio, to either group A or group B.

Group A received an oral dose (250 LSU) of sulodexide bid 7 days prior to scheduled sclerotherapy that continued for 3 months.

Group B received the standard sclerotherapy protocol.

Photographic control was taken, and follow-up was done at 1 and 3 months. With the aid of computer software, the treated area was compared for the variables of incidence of pigmentation, the total area of pigmentation, skin-tone increase in pigmented area, vein disappearance, and incidence of major bleeding.

Intervention type

Drug

Phase

Not Applicable

Drug names

Suldexide 250 LSU bid oral dose for 3 months
Polidocanol 1% 10ml maximum dose per session

Primary outcome measure

1. Incidence of post sclerotherapy hyperpigmentation measured using computer software at baseline, 1 and 3 months
2. Total area of hyperpigmentation measured using computer software at baseline, 1 and 3 months

Secondary outcome measures

1. Presence of major bleeding measured using computer software at baseline, 1 and 3 months
2. Clinical response of vein disappearance measured using computer software at baseline, 1 and 3 months

Overall trial start date

01/06/2017

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 to 65 years
2. Telangiectatic, reticular, or varicose veins in lower limbs
3. Candidate for sclerotherapy
4. BMI 20 to 40 kg/m2
5. Fitzpatrick skin tone I – V
6. Signed consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Total final enrolment

720

Participant exclusion criteria

1. Acute thrombosis
2. History of deep vein thrombosis
3. Deep vein reflux
4. Saphenous vein reflux
5. Pregnancy
6. Bed confinement
7. Long term use of steroidal or nonsteroidal anti-inflammatory drugs (such as corticoids, methotrexate, etc.)
8. Severe leg edema

Recruitment start date

01/01/2018

Recruitment end date

01/08/2019

Locations

Countries of recruitment

Mexico

Trial participating centre

CLINEDEM
Clinic of Dental and Medical Specialties (CLINEDEM) Callejón 5 de Mayo and Calle 7 No. 791 Planta Alta
San Luis Rio Colorado
83449
Mexico

Trial participating centre

ISSSTECALI
Av. Calafia No 1115 - 1G Centro Civico
Mexicali
21000
Mexico

Trial participating centre

Hospital General Issste 5 de Diciembre
Calzada independencia Centro Civico
Mexicali
21000
Mexico

Sponsor information

Organisation

CLINEDEM

Sponsor details

Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico
+526535367497
alex8as2@yahoo.com.mx

Sponsor type

Hospital/treatment centre

Website

http://clinedem.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned application for a paper publication and meeting oral presentation

IPD sharing statement:
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication

Intention to publish date

17/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/05/2020: The basic results of this trial have been uploaded as an additional file. 20/04/2020: Trial’s existence confirmed by the International Union of Phlebology.