Clinical trial NCT06849024: Electrostimulation in Patients with Leg Ulcers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: leg venous ulcers
TENS
electrical stimulation
Lead sponsor: Centro Universitario de Tonalá
Sponsor class: OTHER
Collaborators: name: Diabetes sin complicaciones S.A de C.V
name: Instituto Mexicano del Seguro Social
First posted: 2025-02-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities
timeFrame: From the beginning of treatment at 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Medico Nacional de Occidente. Hospital de Especialidades. Instituto Mexicano del Seguro Social
state: Jalisco
Study officials:
References: