Health Trials

Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)

ConditionLeg Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires URGO

About this trial

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study

Eligibility criteria

Qualifiers

Adult patient (≥ 18 years old), having given free, informed and written consent

Patient affiliated to a social security scheme

Patient agreeing to wear the study compression system daily

Patient with an ankle circumference between 18 and 25 cm

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)
  • Light compression system of the mixed leg ulcer stage C6 / C6r of the CEAP classification

Treatment groups

210 Participants
are divided into 2 treatment groups

Locations

3
Patricia SENET, Paris, Paris 7500075000, ParisParis, France
Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON69007, Lyon France
APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 2075970, Paris France

Sponsors and collaborators

Laboratoires URGO

Lead sponsor

Source ClinicalTrials.gov