Venous Leg UlcerNCT06849024
Electrostimulation in Patients with Leg Ulcers
A study testing Transcutaneous electrical neurostimulation in people with Venous Leg Ulcer, run by Centro Universitario de Tonalá at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Transcutaneous electrical neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2018to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Medico Nacional de Occidente. Hospital de Especialidades. Instituto Mexicano del Seguro Social
Guadalajara, Jalisco
About this study
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
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
- Being tested
- Transcutaneous electrical neurostimulation
- Keywords
- leg venous ulcers, TENS, electrical stimulation
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical neurostimulationDevice
Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A Electrostimulation | Experimental | Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. Receives: 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. Receives: Device: Transcutaneous electrical neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the beginning of treatment at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2018
- Primary completion21 May 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Tonalá
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes sin complicaciones S.A de C.V, Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Arieh Roldán Mercado Sesma, Centro Universitario de Tonalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849024
- Sponsor's protocol ID
- TENS-EC01-2021
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06849024
- Acronym / sponsor ID
- TENS-EC01-2021
- Conditions
- Venous Leg Ulcer
- Keywords
- leg venous ulcers, TENS, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centro Universitario de TonaláUniversity, hospital or other
- Collaborators
- Diabetes sin complicaciones S.A de C.V, Instituto Mexicano del Seguro Social
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Electrostimulation | Experimental | Device: Transcutaneous electrical neurostimulationTranscutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. |
| Group B Placebo | Sham comparator | Device: Transcutaneous electrical neurostimulationTranscutaneous electrical nerve stimulation without stimulation during 30 minutes three times per week for 60 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical neurostimulationTranscutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. | Device | Group A Electrostimulation, Group B Placebo |
Primary outcome
Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities
Time frame: From the beginning of treatment at 60 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical neurostimulation in people with Venous Leg Ulcer, run by Centro Universitario de Tonalá at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed in plasma concentration from baseline of pro-inflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities (time frame: From the beginning of treatment at 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.