Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Coloplast

Status and phase

Completed

Phase 4

Conditions

Leg Ulcers

Treatments

Device: URGOTUL

Device: Physiotulle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01238419

FR010WS

Details and patient eligibility

About

The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

Enrollment

188 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue > 70 %)
Patient with venous or predominantly venous leg ulcer with low exsudate
Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
Patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion
Patient available to be monitored for at least 4 weeks
Patient able to answer questionnaires and particularly to evaluate his pain

Exclusion criteria

Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection *)* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
Patient requiring an analgesic treatment for the care (before dressing removal)
Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
Patient with arterial ulcer
Patient with purely traumatic, infectious or neoplastic origin ulcer
Patient with a diabetic neuropathy of lower limbs
Patient with a known allergy to one of Physiotulle or Urgotul components
Patient already participating in another clinical study
Pregnant or breastfeeding patient

Patient who have been taking corticoids > 10mg / day or cytostatics by systematic way for the three months prior to inclusion

Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion