Electrostimulation in Patients with Leg Ulcers

NCT06849024 | Completed

• 1 other identifier: TENS-EC01-2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Keywords

leg venous ulcers; TENS; electrical stimulation

Outcome Measures

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

  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

  From the beginning of treatment at 60 days

Study Arms (2)

Group A Electrostimulation

EXPERIMENTAL

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

Device: Transcutaneous electrical neurostimulation

Group B Placebo

SHAM COMPARATOR

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

Device: Transcutaneous electrical neurostimulation

Interventions

Transcutaneous electrical neurostimulation DEVICE

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

Group A Electrostimulation; Group B Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario de Tonalá: lead
• Diabetes sin complicaciones S.A de C.V: collaborator
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

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

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate B professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2018
• Primary Completion: May 21, 2022
• Study Completion: July 18, 2022
• Last Updated: February 27, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)