James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This will be a prospective, randomized, single blinded, controlled study in a single center setting to assess the effect of either phototherapy with the Embar® light therapy or sham irradiation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Photobiomodulation on Healing of Venous Leg Ulcers

NCT07123285

Venous Disease Venous Insufficiency (Chronic)(Peripheral) Venous Insufficiency of Leg +5 more

NOT_YET_RECRUITING NA

Light Therapy in the Treatment of Leg Pain

NCT00253981

Tibial Fractures Leg Injuries

TERMINATED NA

Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

NCT01561170

Chronic Venous Hypertension With Ulcer and Inflammation Venous Ulcer Pain

UNKNOWN

Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy

NCT03716167

Venous Leg Ulcer

RECRUITING NA

Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation

NCT02101645

Patients With Lower Extremity Venous Ulcers Patients With Localized Edema

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be a prospective, randomized, single blinded, controlled study in a single center setting. Patients with burn wounds will be screened for enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated the first 48 to 72 hours with a hydrocolloid gel (Flaminal®) combined with Vaseline gauze. Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for Laser Doppler imaging, the burn wounds will be meticulously debrided during dressing changes. Patients whose burn wound meet the inclusion criteria will be randomized to receive either phototherapy with the Embar® light therapy or sham irradiation. Disinfection and topical treatment of the wounds will be the same in both groups as well as the treatment regimen after wound closure with special pressure garments and hydration.

Clinical wound assessments, wound tracings (if possible) and digital photographs will be conducted at least twice a week till wound healing. Swabs will be taken on admission, the day after laser Doppler imaging and from then on a weekly basis. Primary endpoint is complete epithelialization of the wound, secondary endpoint is maturation of the scar after one year. Follow-Ups will be performed one, three, six and twelve months after wound closure. The treatment regimen will consist of custom made pressure garments and hydration of the scar. Objective methods will be used during these follow-ups to evaluate elasticity and color of the scar, this by using the Dermalab and the Dermaspectrometer, as well as the Vancouver Scar Scale, a subjective method.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Embar® light therapy or sham irradiation

Phototherapy with the Embar® light therapy or sham irradiation.

Group Type EXPERIMENTAL

Phototherapy with the Embar® light therapy or sham irradiation

Intervention Type PROCEDURE

Phototherapy with the Embar® light therapy or sham irradiation is followed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phototherapy with the Embar® light therapy or sham irradiation

Phototherapy with the Embar® light therapy or sham irradiation is followed.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with expected healing time between 14 and 21 days, flux values between 200 and 600 (Pink-Yellow-Green-Light Blue color)
* All burn wounds with above mentioned values and a maximal size of 8 by 10 cm.
* Wounds treated with a hydrocolloid gel prior to LDI
* All assessments are done during first days before scanning
* Patients wish and possibility to follow the complete treatment schedule till wound healing and participation on complete follow-up schedule
* Informed consent has been obtained

Exclusion Criteria

* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with other healing times (Red and Dark blue color)
* Impossibility to debride necrotic skin prior to LDI measurement
* All burn wounds with values for inclusion but above the maximal wound size
* Wounds treated with other topical ointments than hydrocolloids
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
* Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
* Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this wound healing study
* The plastic surgeon decides that surgery is necessary
* Patients wish to terminate the study
* No informed consent before start of the trial

Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No