Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Phase 4

Completed

• Conditions: Leg Ulcers
• Interventions: Device: Physiotulle; Device: URGOTUL

• Registration Number: NCT01238419
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotulle	Physiotulle	-
Urgotul	URGOTUL	-

Primary Outcome Measures

Name	Time	Method
pain at dressing removal	4 weeks	pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (29)

Bispebjerg ^Hospital; 🇩🇰 Bispebjerg, NV, Denmark

CH Le Mans; 🇫🇷 Le Mans, France

Hôpital Dupuytren; 🇫🇷 Limoges, France

CHU Caremeau; 🇫🇷 Nimes, France

CHRU La Miletrie; 🇫🇷 Poitiers, France

Hôpital lariboisiere; 🇫🇷 Paris, France

CH Cornouailles; 🇫🇷 Quimper, France

Hôpital de Saint Gaudens; 🇫🇷 Saint Gaudens, France

Centre hospitalier intercommunal; 🇫🇷 Saint Germain en Laye, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHIVA; 🇫🇷 Foix, France

Hôpital Corention Celton; 🇫🇷 Issy les Moulineaux, France

Clinique Mathilde; 🇫🇷 Rouen, France

HIA Sainte Anne; 🇫🇷 Toulon, France

CHRU Tours; 🇫🇷 Tours, France

Cabinet Medical; 🇫🇷 Sarrebourg, France

Hôpital jacques Monod; 🇫🇷 Montivilliers, France

CH; 🇫🇷 Valenciennes, France

Arhus Sygehus; 🇩🇰 Arhus, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

Cabilet Medical; 🇫🇷 Abbeville, France

CHU Sud; 🇫🇷 Amiens, France

Centre Hospitalier; 🇫🇷 Haguenau, France

Hôpital de Freyming; 🇫🇷 Freyming Merleback, France

Cabinet Médical; 🇫🇷 Luneville, France

CHU; 🇫🇷 Caen, France

Hôpital Manchester; 🇫🇷 Charlevilles Mézières, France

Centre Hospitalier de Douai; 🇫🇷 Douai, France

CHD Les Oudairies; 🇫🇷 La Roche sur Yon, France