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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Physiotulle; Device: URGOTUL

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Arhus, Denmark, 8000
    • Århus Sygehus
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
  • NV
    • Bispebjerg, NV, Denmark, 2400
      • Bispebjerg ^Hospital
• France
  • Abbeville, France, 80100
    • Cabilet Medical
  • Amiens, France, 80054
    • CHU Sud
  • Angouleme, France, 16000
    • Cabinet Medical
  • Arras, France, 62022
    • Centre Hospitalier
  • Bagnoles de L'Orne, France, 61140
    • Cabinet Medical
  • Brest, France, 29609
    • CHU
  • Caen, France, 14033
    • CHU
  • Charlevilles Mézières, France, 80011
    • Hôpital Manchester
  • Douai, France, 59507
    • Centre Hospitalier de Douai
  • Foix, France, 09000
    • CHIVA
  • Freyming Merleback, France, 57804
    • Hôpital de Freyming
  • Haguenau, France, 67504
    • Centre Hospitalier
  • Issy les Moulineaux, France, 92133
    • Hôpital Corention Celton
  • La Roche sur Yon, France, 85925
    • CHD Les Oudairies
  • Le Mans, France, 72000
    • CH Le mans
  • Lille, France, 59000
    • Cabinet Medical
  • Limoges, France, 87042
    • Hôpital Dupuytren
  • Luneville, France, 54300
    • Cabinet Medical
  • Montivilliers, France, 76290
    • Hopital Jacques Monod
  • Nimes, France, 30900
    • CHU Caremeau
  • Paris, France, 75475
    • Hôpital Lariboisière
  • Poitiers, France, 86021
    • CHRU La Milétrie
  • Quimper, France, 29107
    • CH Cornouailles
  • Rouen, France, 76175
    • Clinique Mathilde
  • Saint Gaudens, France, 31806
    • Hôpital de Saint Gaudens
  • Saint Germain en Laye, France, 78105
    • Centre Hospitalier Intercommunal
  • Sarrebourg, France, 57400
    • Cabinet Medical
  • Toulon, France, 83000
    • HIA Sainte Anne
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Tours, France, 37044
    • CHRU Tours
  • Valenciennes, France, 59322
    • CH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physiotulle	Device: Physiotulle; Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
PLACEBO_COMPARATOR: Urgotul	Device: URGOTUL; Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain at dressing removal	pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion	4weeks
Number of patients with adverse events as a measure of safety and tolerability	4 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (ESTIMATE): November 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2011
• Last Update Submitted That Met QC Criteria: September 2, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: FR010WS