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

Hadassah Medical Organization

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Conditions

Diabetic Foot Ulcer

Interventions

standard hoem treatmentDEVICE

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.

LLLT-808 B-cure laser machineDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Known Diabetes mellitus 2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months. 3. No known osteomyelitis. 4. Size of wound: 1-8 cm2. 5. Ages: 21 - 75 6. Gender: male and female Exclusion Criteria: 1. Signs of osteomyelitis. 2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis. 3. There is active osteomyelitis in the bone underlying the ulcer. 4. Pregnant women. 5. Children under 21. 6. Presence of or known cancerous comorbidity.

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers

the efficacy will be assesed using measurement of wound depth.

Secondary Outcomes

safety

safety will be evaluated by counting advese events in each group.

Central Contacts

Meir Liebergall, Prof.

CONTACT

972-2-6776342

Data from ClinicalTrials.gov

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