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Physiotulle vs Urgotul in the Treatment of Leg Ulcer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01238419
First received: October 27, 2010
Last updated: September 2, 2011
Last verified: October 2010

October 27, 2010
September 2, 2011
November 2009
May 2011   (final data collection date for primary outcome measure)
pain at dressing removal [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
Same as current
Complete list of historical versions of study NCT01238419 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Physiotulle vs Urgotul in the Treatment of Leg Ulcer
Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leg Ulcers
  • Device: Physiotulle
    Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
  • Device: URGOTUL
    Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
  • Experimental: Physiotulle
    Intervention: Device: Physiotulle
  • Placebo Comparator: Urgotul
    Intervention: Device: URGOTUL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
May 2011
May 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France
 
NCT01238419
FR010WS
No
Coloplast A/S
Coloplast A/S
Not Provided
Not Provided
Coloplast A/S
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP