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
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
- ISRCTN39680155_BasicResults.docx uploaded 18/05/2020