Electrostimulation in Patients with Leg Ulcers

Centro Universitario de Tonalá

Status

Completed

Conditions

Venous Leg Ulcer

Treatments

Device: Transcutaneous electrical neurostimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06849024

TENS-EC01-2021

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.