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A prospective, randomised, controlled Study evaluating the effect of waterfiltered infrared A radiation (wIRA) on wound healing of venous leg ulcers

A prospective, randomised, controlled Study evaluating the effect of waterfiltered infrared A radiation (wIRA) on wound healing of venous leg ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000669
Enrollment
50
Registered
2011-05-18
Start date
2006-07-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I83.2

Interventions

Group 1: Treatment with water filtered infrared A (wIRA) plus standard therapy, with effective irradiation strength of 185mW/cm2 (visible light plus wIRA) and an effecitve infrared A amount of 140mW/c

Sponsors

Universitäts-Hautklinik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients over 18 years with ulcers of the lower legs of predominantly venous genesis (brachio-pedal index >0.6, wedge pressures >60 mm Hg); chronic state (lasting more than 6 weeks with no tendency to heal under the previous therapy); ulcer size of 1–200 cm².

Exclusion criteria

Exclusion criteria: vascular surgical or other vascular interventions in the area of the lower extremities within the last 6 weeks prior to inclusion in the study; prior inclusion in this study; inclusion in an other study at the time of inclusion in this study;physical or mental illnesses (including severe accompanying basic illnesses, e.g. cancer, AIDS, severe anaemia, insufficiently treated diabetes mellitus) which do not allow participation in the treatment procedure of the study; peripheral arterial occlusive disease (with clinical signs for a critical ischaemia, a brachio-pedal index <0.6 or a wedge pressure of the ankle or arch of the foot <60 mm Hg); oral antibiotic treatment of the ulcer

Design outcomes

Primary

MeasureTime frame
Wound closure or wound size reduction of a treatment intervall of maximum 13 weeks.

Secondary

MeasureTime frame
Change of wound exsudation, pain, granulation, coatings, epithelialization during therapy.

Countries

Germany

Contacts

Public ContactHauke Schumann

Universitäts-Hautklinik

hauke.schumann@uniklinik-freiburg.de0761 270 67400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026