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

NCT03229330 | Completed

• 1 other identifier: 15-0634
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer; Low-Level Light Therapy

Keywords

Wound Healing; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

• Decreased Wound Size and Scar formation

  NOC Wound Healing: Second Intention - Greater length (in the cephalopheudial direction) versus greater width, in cm2 evaluated by the Likert scale, being 1 the worst score and 5 best score. NOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as "islands" on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.

  16 weeks

Secondary Outcomes (3)

• Skin thickness

  16 weeks

• Evaluation of Pain

  16 weeks

• Overall improvement of other NOC indicators correlated.

  16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: Low-level Light Therapy; Combination Product: Conventional treatment

Controls

ACTIVE COMPARATOR

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

Combination Product: Conventional treatment

Interventions

Low-level Light Therapy PROCEDURE

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

Also known as: Wavelength of 660 nm, red laser

Intervention

Conventional treatment 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

Also known as: Topical and compressive treatments

Controls; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30001202 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Amália De Fátima Lucena

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All subjects involved are aware of the procedures applied due to the features of the therapies used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 25, 2017
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 27, 2019

Record last verified: 2017-07

Locations

BR (1)