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Monochromatic Phototherapy on Diabetic Foot Ulcers

NCT00859599 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2011-06-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of monochromatic phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo phototherapy as a complementary to standard diabetic foot ulcer therapy.

The study initiated with a four week long Run In Period to eliminate spontaneous healing ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan. The area of the ulcer will be measured once weekly for 20 weeks or until the ulcer is completely healed.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

Monochromatic phototherapy, Biolight®

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

DEVICE

Monochromatic phototherapy

Monochromatic phototherapy (Biolight®) will be given locally, additional to standard care, three times weekly during the first four weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed, according to a pre-determined treatment plan.

Sponsors & Collaborators

  • Biolight AB

    lead INDUSTRY

Principal Investigators

  • Jan Apelqvist, M.D., Ph.D. · Malmö University Hospital, Department of Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-12-31
Completion
2012-04-30

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859599 on ClinicalTrials.gov