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Electrostimulation in Patients with Leg Ulcers

NCT06849024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-27

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Transcutaneous electrical neurostimulation

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

Sponsors & Collaborators

  • Diabetes sin complicaciones S.A de C.V

    collaborator UNKNOWN

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Centro Universitario de Tonalá

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-05-21
Completion
2022-07-18

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849024 on ClinicalTrials.gov