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Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds

NCT01493895 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-03-22

No results posted yet for this study

Summary

For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

standard hoem treatment

All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.

DEVICE

LLLT-808 B-cure laser machine

From the day of entering the study, ulcers will be treated twice daily regardless of the treatment that was used until then. All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method. The part of the laser machine from which the laser beam is radiating - the beam guard, will be cleaned with a disposable swab of 70% alcohol. The cleaning will be performed while the machine is pointing downwards.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493895 on ClinicalTrials.gov