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Completed

NCT Number: NCT01238419

Physiotulle vs Urgotul in the Treatment of Leg Ulcer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg ^Hospital, Bispebjerg, NV, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotulle

Device

Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline

URGOTUL

Device

Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix

Primary outcomes

  1. pain at dressing removal

    Time frame: 4 weeks

    pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale

Secondary outcomes

  1. Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion

    Time frame: 4weeks

  2. Number of patients with adverse events as a measure of safety and tolerability

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2010
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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