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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcer

Treatments: Device: standard hoem treatment; Device: LLLT-808 B-cure laser machine

Study type: Interventional

Funder types: Other

Identifiers

NCT01493895

becure-CTIL-HMO

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

control group,

Active Comparator group

Description:

The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.

Treatment:

Device: standard hoem treatment

study, LLLT-808 B-cure laser machine

Experimental group

Description:

The study group will be treated with the LLLT-808 B-cure laser machine, emitting the 808nm laser beam together with a green indicator light.

Treatment:

Device: LLLT-808 B-cure laser machine