Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial

Matheus Bertanha, Paula Angeleli Bueno de Camargo, Regina Moura, Winston Bonetti Yoshida, Rafael Elias Farres Pimenta, Jamil Victor de Oliveira Mariúba, Giovana Piteri Alcantara, Dênia Reis de Paula, Marcone Lima Sobreira, Matheus Bertanha, Paula Angeleli Bueno de Camargo, Regina Moura, Winston Bonetti Yoshida, Rafael Elias Farres Pimenta, Jamil Victor de Oliveira Mariúba, Giovana Piteri Alcantara, Dênia Reis de Paula, Marcone Lima Sobreira

Abstract

Background: Telangiectasias are defined as small venules abnormally dilated, located in the intradermal portion of the skin, of reddish or bluish tinge, their diameter not exceeding 1 mm; they are classified by the American Venous Forum as mild venous disease CEAP C1. Conventional treatment consists of chemical sclerotherapy, considered a minimally invasive technique with rapid clinical recovery. A wide variety of sclerosing solutions can be used for this purpose.

Methods/design: This project intends to include 96 patients that will be randomized to a triple-blind study. Inclusion criteria are women between 18 and 65 years, with telangiectasia on the lateral thigh. Male patients, female patients with chronic venous disease CEAP 2 to 6, women with allergies, pregnant, breastfeeding, with any type of skin problems or any decompensated clinical disease will be excluded. All patients included will be submitted to venous ultrasound mapping in order to rule out venous disease not clinically visible, deep venous system insufficiency, and insufficiency of the ostial valve of the great saphenous vein. One group will be treated with glucose 75% solution and the other will receive polidocanol 0.2% diluted in glucose 70%. Each patient will receive only 1 treatment session in 1 single member. The volume of sclerosing solution will not exceed 5 mL and the treatment area will be limited to a region of 150 cm on the lateral thigh. Clinical follow-up will be: 1 initial visit, when the clinical report will be filled; photographic record and treatment with sclerotherapy (D0); follow-up visits after 7 and 60 days (D7 and D60, respectively), always with clinical and photographic documentation.

Discussion: The project intends to evaluate the efficacy and safety of sclerotherapy in eliminating telangiectasia in a predetermined area in order to establish efficacy and safety parameters for the treatments presented.

Conclusion: This protocol for clinical trial will provide date to determine the efficacy and safety of sclerotherapy with the solutions presented.

Trial registration identifier: ClinicalTrial.gov NCT02657252 Date: 01/12/2016 (retrospectively registered).

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Schematic representation of the treatment area in this study.
Figure 2
Figure 2
Assessment form to be filled by the patient after the treatment.
Figure 3
Figure 3
Instructions sheet for patients after the sclerotherapy treatment for telangiectasia.
Figure 4
Figure 4
Flowchart of patients in the study.

References

    1. Goldman MP, Bennett RG. Treatment of telangiectasia: a review. J Am Acad Dermatol 1987; 17:167–182.
    1. Beebe HG, Bergan JJ, Berggvist D, et al. Classification and grading of chronic venous disease in the lower limbs–a consensus statement. Organized by Straub Foundation with the cooperation of the American Venous Forum at the 6th annual meeting, February 22–25, 1994, Maui, Hawaii. VASA. Zeitschrift für Gefässkrankheiten 1995; 24:313.
    1. Eklöf BO, Rutherford RB, Bergan JJ, et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40:1248–1252.
    1. Springer India, Vaidyanathan S. Venous Telangiectasia and Reticular Veins: Clinical Class C1. Chronic Venous Disorders of the Lower Limbs. 2015; 207–213.
    1. Benigni JP, Bihari I, Rabe E, et al. UIP—Union Internationale de Phlébologie Venous symptoms in C0 and C1 patients: UIP consensus document. Int Angiol 2013; 32:261–265.
    1. Tepavcevic B, Predrag M, Djordje R. Comparison of sclerotherapy, laser, and radiowave coagulation in treatment of lower extremity telangiectasias. J Cosmetic Laser Ther 2012; 14:239–242.
    1. Drake LA, Dinehart CSM, Goltz RW, et al. Guidelines of care for sclerotherapy treatment of varicose and telangiectatic leg veins. J Am Acad Dermatol 1996; 34:523–528.
    1. Goldman MP. Laser and sclerotherapy treatment of leg veins: my perspective on treatment outcomes. Dermatol Surg 2002; 28:969.
    1. Hobbs JT. Surgery and sclerotherapy in the treatment of varicose veins: a random trial. Arch Surg 1974; 109:793.
    1. Peterson JD, Goldman MP, Weiss RA, et al. Treatment of reticular and telangiectatic leg veins: double-blind, prospective comparative trial of polidocanol and hypertonic saline. Dermatol Surg 2012; 38:1322–1330.
    1. McCoy S, Evans A, Spurrier N. Sclerotherapy for leg telangiectasia—a blinded comparative trial of polidocanol and hypertonic saline. Dermatol Surg 1999; 25:381–386.
    1. Palm MD, Guiha IC, Goldman MP. Foam sclerotherapy for reticular veins and nontruncal varicose veins of the legs: a retrospective review of outcomes and adverse effects. Dermatol Surg 2010; 36:1026–1033.
    1. Duffy DM. Sclerosants: a comparative review. Dermatol Surg 2010; 36:1010–1025.
    1. Ceulen RP, Sommer A, Vernooy K. Microembolism during foam sclerotherapy of varicose veins. N Engl J Med 2008; 358:1525–1526.
    1. Marrocco–Trischitta MM, Guerrini P, Abeni D, et al. Reversible cardiac arrest after polidocanol sclerotherapy of peripheral venous malformation. Dermatol Surg 2002; 28:153–155.
    1. Kern P, Ramelet AA, Wutschert R, et al. Single blind, randomized study comparing chromated glycerin, polidocanol solution, and polidocanol foam for treatment of telangiectatic leg veins. Dermatol Surg 2004; 30:367–372.
    1. Kobayashi S, Crooks S, Eckmann DM. Dose and time dependent liquid sclerosant effects on endothelial cell death. Dermatol Surg 2006; 32:1444–1452.
    1. Bertanha M, Sobreira ML, Lucio-Filho CEP, et al. Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial. Trials 2014; 15:497.
    1. Rabe E, Pannier-Fischer F, Gerlach H, et al. German Society of Phlebology: Guidelines for sclerotherapy of varicose veins (ICD 10: I83. 0, I83. 1, I83. 2, and I83. 9). Dermatol Surg 2004; 30:687–693.
    1. Rabe E, Breu F, Cavezzi A, et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2013; 29:338–354.

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