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| Name | Class |
|---|---|
| Diabetes sin complicaciones S.A de C.V | UNKNOWN |
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Electrostimulation | Experimental | Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. |
|
| Group B Placebo | Sham Comparator | Transcutaneous electrical nerve stimulation without stimulation during 30 minutes three times per week for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical neurostimulation | Device | Transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico Nacional de Occidente. Hospital de Especialidades. Instituto Mexicano del Seguro Social | Guadalajara | Jalisco | Mexico |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |