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Home » Clinical Trials » Diabetic Foot Ulcers

Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using Monochromatic phototherapy, Biolight® and Monochromatic phototherapy for patients with Diabetic Foot Ulcers

Research Study Title

Monochromatic Phototherapy on Diabetic Foot Ulcers. A Twenty Weeks Prospective, Randomised, Double Blind, Multi-centre, Placebo Controlled Study

Purpose

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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Biolight AB

Duration

40 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Wagner grade 1-2 (superficial or deep ulcer)

  • Size of ulcer 1 -25 cm2

  • Localisation of the ulcer below the ankle

  • Systolic ankle blood pressure > 80 mmHg or

  • Systolic toe blood pressure > 45 mmHg equal to and higher than or only

  • Type 1 or II diabetes - Previously known diabetes according to WHO criteria

  • HbA1c < 12

  • 18 year

  • Willing and able to fulfil the study requirements

  • Written informed consent

Exclusion Criteria:

  • Earlier participation in this study

  • Life-threatening malignancy

  • Systemic, oral use of corticosteroid preparations ( > 7.5 mg Prednisolon)

  • Immunosuppressive treatment such as cytostatic drugs and TNF-antagonists

  • Kidney insufficiency (Creatinine > 250 micromol/l)

  • Clinical signs of infections

  • Antibiotic treatment the last two weeks

  • Suspected venous genesis

  • More than two ulcers per foot

  • Wagner grade 3-5

  • Location of ulcers making treatment or evaluation not feasible

  • Photosensitivity or other sensitivity to electromagnetic radiation

  • Pregnancy or breastfeeding

  • Participation in any clinical study the last three month

Site Locations (4)

Country State City Zip Facility and Contact
Sweden Skåne Ängelholm SE-452 80 Department of Medicine
Anders Nilsson, Dr
+46 431 817 85
anders.l.nilsson@skane.se

Anders Nilsson, Dr
Principal Investigator
Sweden Halmstad SE-301 85 Regional Hospital, Halmstad
Stefan Sjöberg, Ass prof
+46 35 17 43 96
Stefan.sjoberg@lthalland.se

Stefan Sjöberg, Ass prof
Principal Investigator
Sweden Lund SE-221 85 Lund University Hospital
Magnus Löndahl, Dr
+46 46 17 22 35
Magnus.Londahl@skane.se

Magnus Löndahl, Dr
Principal Investigator

Per Katzman, Ass prof
Sub-Investigator
Sweden Malmö SE-205 02 Malmö University Hospital
Jan Apelqvist, Ass prof
+46 40 33 23 84
jan.apelqvist@skane.se

Jan Apelqvist, Ass Prof
Principal Investigator

Contact

Hans Johansson
+46 31 336 91 02
E-mail:

NCT ID: NCT00859599

Date Last Changed: June 7, 2011

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