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

Status:

UNKNOWN

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

Lead Sponsor:

Hadassah Medical Organization

Conditions:

Diabetic Foot Ulcer

Eligibility:

All Genders

21-75 years

Phase:

PHASE1

PHASE2

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 u...

Eligibility Criteria

Inclusion

Known Diabetes mellitus
With an active chronic wound in the foot, that has been treated conventionally for over 3 months.
No known osteomyelitis.
Size of wound: 1-8 cm2.
Ages: 21 - 75
Gender: male and female

Exclusion

Signs of osteomyelitis.
The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.
There is active osteomyelitis in the bone underlying the ulcer.
Pregnant women.
Children under 21.
Presence of or known cancerous comorbidity.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01493895

Last Update

March 22 2013

Active Locations (1)

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