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Completed

NCT Number: NCT06849024

Electrostimulation in Patients with Leg Ulcers

Abstract Evaluate the effect of transcutaneous electrical nerve stimulation on proinflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities.

Material and Methods A randomized, double-blind, placebo-controlled, parallel-groups clinical trial was carried out in 32 adults (18-75 years of age) with venous ulcers of the lower extremities according to CEAP classification with duple Doppler ultrasound. After random allocation of intervention 16 patients received continuous and intermittent transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. Proinflammatory cytokines, angiogenic and growth factors were measured before and after intervention. Mann-Whitney U test and Wilcoxon's rank-sum test were performed to statistical analyses.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Nacional de Occidente. Hospital de Especialidades. Instituto Mexicano del Seguro Social

Guadalajara, Jalisco, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Venous ulcers C6,Es, As/Ap,Pr according to CEAP classification by Spanish Society of Angiology and Vascular Surgery or demonstrated with duplex Doppler ultrasound
  • Who did not respond to conventional treatment.
  • Evolution of no less than 12 weeks
  • Ulcers with a size > 2 and < 12 cm in any of its dimensions did not affect the dermis and epidermis, but should not spread to the tendon or bone, without formation of ischemia and infection.

Exclusion criteria

  • Patients with active superficial or deep thrombus phlebitis, chronic arterial insufficiency (figures less than 0.8 in IPTB), neoplasms.
  • Treated with chemotherapy or radiation therapy
  • Clinically infected ulcers at the time of study evaluation, signs of cellulitis.
  • Osteomyelitis or ulcer with a necrotic background Individuals with a surgical history of venous insufficiency at least 12 months prior to undergoing the protocol.
  • Participants with diseases such as rheumatoid arthritis, lupus erythematosus, or disseminated, mental diseases, electrical implants (bypass), pregnancy and breastfeeding, diabetes mellitus, lung cancer, a history of stroke, or undergoing anticoagulant treatment.
  • Patients receiving corticosteroids or some other immunosuppressive, non-steroidal anti-inflammatory, histamine antagonists, or antibiotics on a regular basis within 4 weeks prior to the study.

Treatment and study plan

Transcutaneous electrical neurostimulation

Device

Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days.

Primary outcomes

  1. Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities

    Time frame: From the beginning of treatment at 60 days

    Changed in plasma concentration from baseline of EGF, VEGF, PDGF-BB, TNF-, IL-1, IL-6, TSP-1 and TIMP-1 and 2 from basa to 60 days

Sponsors and collaborators

Lead sponsor

Centro Universitario de Tonalá

Other

Collaborators

  • Diabetes sin complicaciones S.A de C.V
  • Instituto Mexicano del Seguro Social

Registry information

Official study title

Effect of Transcutaneous Electrical Nerve Stimulation on Proinflammatory Cytokines, Angiogenic and Growth Factors in Subjects with Venous Ulcers of the Lower Extremities: a Clinical Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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