Electrostimulation in Patients with Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-07-18

Brief Summary

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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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Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A Electrostimulation

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

Group Type EXPERIMENTAL

Transcutaneous electrical neurostimulation

Intervention Type DEVICE

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

Group B Placebo

Transcutaneous electrical nerve stimulation without stimulation during 30 minutes three times per week for 60 days.

Group Type SHAM_COMPARATOR

Transcutaneous electrical neurostimulation

Intervention Type DEVICE

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

Interventions

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Transcutaneous electrical neurostimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No