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
Reducing Hyperpigmentation After Sclerotherapy (RHyAS) study: a multicenter, randomized, clinical trial.
The use of sulodexide in patients with varicose vein treated with sclerotherapy can reduce the incidence of hyperpigmentation
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; firstname.lastname@example.org)
Prospective, multicentric, randomized controlled trial, using a parallel-group design
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Hyperpigmentation following sclerotherapy for varicose veins
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.
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Acute thrombosis
2. History of deep vein thrombosis
3. Deep vein reflux
4. Saphenous vein reflux
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
Recruitment end date
Countries of recruitment
Trial participating centre
Clinic of Dental and Medical Specialties (CLINEDEM) Callejón 5 de Mayo and Calle 7 No. 791 Planta Alta
San Luis Rio Colorado
Trial participating centre
Av. Calafia No 1115 - 1G Centro Civico
Trial participating centre
Hospital General Issste 5 de Diciembre
Calzada independencia Centro Civico
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
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
Participant level data
To be made available at a later date
Basic results (scientific)
- ISRCTN39680155_BasicResults.docx uploaded 18/05/2020