Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)

NCT ID: NCT03229330

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-12-31

Brief Summary

This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.

Detailed Description

There are several therapeutics with different mechanisms of action to reach tissue repair.

The conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications.

Despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. Therefore, Low-level Light Therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. This therapy contributes to accelerate and improve the tissue repair process.

Studies assessed by Nursing Outcomes Classification about the usage of the treatments above combined are not available. Consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.

Conditions

Venous Ulcer; Low-Level Light Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Low-level Light Therapy: Wavelength of 660 nm (red laser) and Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.

Group Type: EXPERIMENTAL

Low-level Light Therapy

Intervention Type: PROCEDURE

Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.

Conventional treatment

Intervention Type: COMBINATION_PRODUCT

Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress

Controls

Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: COMBINATION_PRODUCT

Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress

Interventions

Low-level Light Therapy

Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.

Intervention Type: PROCEDURE

Conventional treatment

Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Wavelength of 660 nm; red laser; Topical and compressive treatments

Eligibility Criteria

Inclusion Criteria

• Presence of venous ulcer
• Availability for weekly appointment
• Acceptance to participate of the research with the signature of the Term of Free and Informed Consent

Exclusion Criteria

• Morbid obesity
• Active cancer treatment
• Erysipelas
• Cellulitis, lymphangitis and chronic lymphedema
• Usage of immunosuppressants and / or corticosteroids
• Venous ulcer all around the leg
• Presence of coagulation necrosis covering more than 25% of the wound bed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amália De Fátima Lucena

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.

Reference Type: DERIVED

PMID: 30001202 (View on PubMed)

Other Identifiers

15-0634

Identifier Type: -

Identifier Source: org_study_id