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

NCT ID: NCT01493895

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

control group,

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

Group Type: ACTIVE_COMPARATOR

standard hoem treatment

Intervention Type: DEVICE

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.

study, 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.

Group Type: EXPERIMENTAL

LLLT-808 B-cure laser machine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Meir Liebergall, Prof.

Role: CONTACT

972-2-6776342

References

Haze A, Gavish L, Elishoov O, Shorka D, Tsohar T, Gellman YN, Liebergall M. Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study. Lasers Med Sci. 2022 Mar;37(2):919-928. doi: 10.1007/s10103-021-03335-9. Epub 2021 May 29.

Reference Type: DERIVED

PMID: 34052927 (View on PubMed)

Other Identifiers

becure-CTIL-HMO

Identifier Type: -

Identifier Source: org_study_id