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

Phase 1

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: standard hoem treatment; Device: LLLT-808 B-cure laser machine

• Registration Number: NCT01493895
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group,	standard hoem treatment	The control group will be treated with a sham B-cure laser machine, emitting only green indicator light and no 808nm laser.
study, LLLT-808 B-cure laser machine	LLLT-808 B-cure laser machine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel