Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Leg Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238419
• Other study ID #: FR010WS
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: September 2, 2011
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2010
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer

Intervention

Device:
• Physiotulle
Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
• URGOTUL
Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix

Locations

Country	Name	City	State
Denmark	Arhus Sygehus	Arhus
Denmark	Bispebjerg ^Hospital	Bispebjerg	NV
Denmark	Odense Universitets Hospital	Odense
France	Cabilet Medical	Abbeville
France	CHU Sud	Amiens
France	Cabinet Medical	Angouleme
France	Centre Hospitalier	Arras
France	Cabinet Médical	Bagnoles de L'Orne
France	CHU	Brest
France	CHU	Caen
France	Hôpital Manchester	Charlevilles Mézières
France	Centre Hospitalier de Douai	Douai
France	CHIVA	Foix
France	Hôpital de Freyming	Freyming Merleback
France	Centre Hospitalier	Haguenau
France	Hôpital Corention Celton	Issy les Moulineaux
France	CHD Les Oudairies	La Roche sur Yon
France	CH Le Mans	Le Mans
France	Cabinet Medical	Lille
France	Hôpital Dupuytren	Limoges
France	Cabinet Médical	Luneville
France	Hôpital jacques Monod	Montivilliers
France	CHU Caremeau	Nimes
France	Hôpital lariboisiere	Paris
France	CHRU La Miletrie	Poitiers
France	CH Cornouailles	Quimper
France	Clinique Mathilde	Rouen
France	Hôpital de Saint Gaudens	Saint Gaudens
France	Centre hospitalier intercommunal	Saint Germain en Laye
France	Cabinet Medical	Sarrebourg
France	HIA Sainte Anne	Toulon
France	Clinique Pasteur	Toulouse
France	CHRU Tours	Tours
France	CH	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain at dressing removal	pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale	4 weeks	No
Secondary	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	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability		4 weeks	Yes