ISRCTN ISRCTN39680155
DOI https://doi.org/10.1186/ISRCTN39680155
Secondary identifying numbers 8936-042019
Submission date
03/04/2020
Registration date
20/04/2020
Last edited
11/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Alejandro Gonzalez Ochoa
Scientific

Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico

ORCiD logoORCID ID 0000-0001-5068-623X
Phone +526538497372
Email 2alex8as@gmail.com

Study information

Study designProspective, multicentric, randomized controlled trial, using a parallel-group design
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleReducing Hyperpigmentation After Sclerotherapy (RHyAS) study: a multicenter, randomized, clinical trial.
Study acronymRHyAS study
Study objectivesThe use of sulodexide in patients with varicose vein treated with sclerotherapy can reduce the incidence of hyperpigmentation
Ethics approval(s)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)
Health condition(s) or problem(s) studiedHyperpigmentation following sclerotherapy for varicose veins
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Suldexide 250 LSU bid oral dose for 3 months Polidocanol 1% 10ml maximum dose per session
Primary outcome measure1. 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 measures1. 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 study start date01/06/2017
Completion date01/09/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants600
Total final enrolment720
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2018
Date of final enrolment01/08/2019

Locations

Countries of recruitment

  • Mexico

Study participating centres

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
ISSSTECALI
Av. Calafia No 1115 - 1G
Centro Civico
Mexicali
21000
Mexico
Hospital General Issste 5 de Diciembre
Calzada independencia
Centro Civico
Mexicali
21000
Mexico

Sponsor information

CLINEDEM
Hospital/treatment centre

Callejón 5 de Mayo and Calle 7 No. 791
Planta Alta
San Luis Rio Colorado
83449
Mexico

Phone +526535367497
Email alex8as2@yahoo.com.mx
Website http://clinedem.com/

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date17/06/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned application for a paper publication and meeting oral presentation
IPD sharing planThe datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 18/05/2020 No No
Results article results 01/01/2021 11/12/2020 Yes No

Additional files

ISRCTN39680155_BasicResults.docx
uploaded 18/05/2020

Editorial Notes

11/12/2020: Publication reference added.
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.