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Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Primary Purpose

Leg Ulcers

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Physiotulle
URGOTUL
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bispebjerg ^Hospital
  • Arhus Sygehus
  • Odense Universitets Hospital
  • Cabilet Medical
  • CHU Sud
  • Cabinet Medical
  • Centre Hospitalier
  • Cabinet Médical
  • CHU
  • CHU
  • Hôpital Manchester
  • Centre Hospitalier de Douai
  • CHIVA
  • Hôpital de Freyming
  • Centre Hospitalier
  • Hôpital Corention Celton
  • CHD Les Oudairies
  • CH Le Mans
  • Cabinet Medical
  • Hôpital Dupuytren
  • Cabinet Médical
  • Hôpital jacques Monod
  • CHU Caremeau
  • Hôpital lariboisiere
  • CHRU La Miletrie
  • CH Cornouailles
  • Clinique Mathilde
  • Hôpital de Saint Gaudens
  • Centre hospitalier intercommunal
  • Cabinet Medical
  • HIA Sainte Anne
  • Clinique Pasteur
  • CHRU Tours
  • CH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Physiotulle

Urgotul

Arm Description

Outcomes

Primary Outcome Measures

pain at dressing removal
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
Number of patients with adverse events as a measure of safety and tolerability

Full Information

First Posted
October 27, 2010
Last Updated
September 2, 2011
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01238419
Brief Title
Physiotulle vs Urgotul in the Treatment of Leg Ulcer
Official Title
Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotulle
Arm Type
Experimental
Arm Title
Urgotul
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Physiotulle
Intervention Description
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
Intervention Type
Device
Intervention Name(s)
URGOTUL
Intervention Description
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
Primary Outcome Measure Information:
Title
pain at dressing removal
Description
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bispebjerg ^Hospital
City
Bispebjerg
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Arhus Sygehus
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Cabilet Medical
City
Abbeville
ZIP/Postal Code
80100
Country
France
Facility Name
CHU Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Cabinet Medical
City
Angouleme
ZIP/Postal Code
16000
Country
France
Facility Name
Centre Hospitalier
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
Cabinet Médical
City
Bagnoles de L'Orne
ZIP/Postal Code
61140
Country
France
Facility Name
CHU
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Manchester
City
Charlevilles Mézières
ZIP/Postal Code
80011
Country
France
Facility Name
Centre Hospitalier de Douai
City
Douai
ZIP/Postal Code
59507
Country
France
Facility Name
CHIVA
City
Foix
ZIP/Postal Code
09000
Country
France
Facility Name
Hôpital de Freyming
City
Freyming Merleback
ZIP/Postal Code
57804
Country
France
Facility Name
Centre Hospitalier
City
Haguenau
ZIP/Postal Code
67504
Country
France
Facility Name
Hôpital Corention Celton
City
Issy les Moulineaux
ZIP/Postal Code
92133
Country
France
Facility Name
CHD Les Oudairies
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH Le Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Cabinet Medical
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Cabinet Médical
City
Luneville
ZIP/Postal Code
54300
Country
France
Facility Name
Hôpital jacques Monod
City
Montivilliers
ZIP/Postal Code
76290
Country
France
Facility Name
CHU Caremeau
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Hôpital lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHRU La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CH Cornouailles
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Clinique Mathilde
City
Rouen
ZIP/Postal Code
76175
Country
France
Facility Name
Hôpital de Saint Gaudens
City
Saint Gaudens
ZIP/Postal Code
31806
Country
France
Facility Name
Centre hospitalier intercommunal
City
Saint Germain en Laye
ZIP/Postal Code
78105
Country
France
Facility Name
Cabinet Medical
City
Sarrebourg
ZIP/Postal Code
57400
Country
France
Facility Name
HIA Sainte Anne
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CH
City
Valenciennes
ZIP/Postal Code
59322
Country
France

12. IPD Sharing Statement

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Physiotulle vs Urgotul in the Treatment of Leg Ulcer

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