Neuromuscular Electrical Therapy in Venous Ulcers

NCT01372020 | Completed Phase 4

• 1 other identifier: fepar-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain. The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

Conditions

Chronic Venous Insufficiency

Keywords

Varicose ulcer; wound healing; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain assessment will be performed by the Visual Analogue Scale

  the subjects will be followed for a period of 4 weeks.

Secondary Outcomes (1)

• ulcer area

  the patients will be folloed for the 4-weeks.

Study Arms (2)

control group

SHAM COMPARATOR

Other: neuromuscular electrical stimulation

neuromuscular electrical therapy

EXPERIMENTAL

Other: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulation OTHER

The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.

Also known as: intervention group

control group; neuromuscular electrical therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of both genders
• aged over 50 years
• sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included

You may not qualify if:

• Subjects with pacemakers
• diabetes
• uncontrolled hypertension
• osteomyelitis and pain of unknown origin
• unable to walk or make use of drugs that acted directly on the healing process will be excluded

Sponsors & Collaborators

• Faculdade Evangelica do Parana: lead

Study Sites (1)

Faculdade Dom Bosco

Curitiba, Paraná, 55, Brazil

Location

Related Publications (2)

• Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.

  PMID: 3893385 RESULT

• Korelo RI, Valderramas S, Ternoski B, Medeiros DS, Andres LF, Adolph SM. Microcurrent application as analgesic treatment in venous ulcers: a pilot study. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):753-60. doi: 10.1590/s0104-11692012000400016. English, Portuguese, Spanish.

  PMID: 22990161 DERIVED

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 Officials

• Korelo Raciele, M.sC

  Facukdade Dom Bosco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Silvia Valderramas

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

BR (1)