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
  Purpose

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.


Condition Intervention Phase
Leg Ulcers
Device: Physiotulle
Device: URGOTUL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 188
Study Start Date: November 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238419

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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01238419     History of Changes
Other Study ID Numbers: FR010WS
Study First Received: October 27, 2010
Last Updated: September 2, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014